CN107567310B - Time-dependent evaluation of sensor data to determine stability, creep and viscoelasticity elements of a measurement - Google Patents

Time-dependent evaluation of sensor data to determine stability, creep and viscoelasticity elements of a measurement Download PDF

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Publication number
CN107567310B
CN107567310B CN201680026011.4A CN201680026011A CN107567310B CN 107567310 B CN107567310 B CN 107567310B CN 201680026011 A CN201680026011 A CN 201680026011A CN 107567310 B CN107567310 B CN 107567310B
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tissue
processor
sensor
jaw member
surgical instrument
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CN107567310A (en
Inventor
F·E·谢尔顿四世
J·L·哈里斯
B·E·斯文斯加德
R·L·莱姆巴赫
S·R·亚当斯
M·D·奥尔梅亚
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Ethicon LLC
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Ethicon LLC
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    • A61B5/053Measuring electrical impedance or conductance of a portion of the body
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Abstract

The invention discloses a powered surgical cutting and stapling instrument. The instrument includes at least one sensor for measuring at least one parameter associated with the instrument, at least one processor, and a memory operatively associated with the processor. The memory includes machine-executable instructions that, when executed by the processor, cause the processor to monitor the at least one sensor for a predetermined period of time and determine a rate of change of the measured parameter.

Description

Time-dependent evaluation of sensor data to determine stability, creep and viscoelasticity elements of a measurement
Background
The present disclosure relates to surgical instruments and, in various instances, to surgical stapling and cutting instruments and staple cartridges therefor that are designed for stapling and cutting tissue.
Drawings
The features and advantages of the present disclosure, as well as the methods of attaining them, will become more apparent and the disclosure will be better understood by reference to the following description of the disclosure in conjunction with the accompanying drawings, wherein:
FIG. 1 is a perspective view of a surgical instrument having an interchangeable shaft assembly operably coupled thereto;
FIG. 2 is an exploded assembly view of the interchangeable shaft assembly and surgical instrument of FIG. 1;
FIG. 3 is another exploded assembly view showing portions of the interchangeable shaft assembly and surgical instrument of FIGS. 1 and 2;
FIG. 4 is an exploded assembly view of a portion of the surgical instrument of FIGS. 1-3;
FIG. 5 is a cross-sectional side view of a portion of the surgical instrument of FIG. 4 with the firing trigger in a fully actuated position;
FIG. 6 is another cross-sectional view of a portion of the surgical instrument of FIG. 5 with the firing trigger in an unactuated position;
FIG. 7 is an exploded assembly view of one form of an interchangeable shaft assembly;
FIG. 8 is another exploded assembly view of portions of the interchangeable shaft assembly of FIG. 7;
FIG. 9 is another exploded assembly view of portions of the interchangeable shaft assembly of FIGS. 7 and 8;
FIG. 10 is a cross-sectional view of a portion of the interchangeable shaft assembly of FIGS. 7-9;
FIG. 11 is a perspective view of a portion of the axle assembly of FIGS. 7-10 with the switch drum omitted for clarity;
FIG. 12 is another perspective view of the interchangeable shaft assembly portion of FIG. 11 with the switch drum mounted thereon;
FIG. 13 is a perspective view of a portion of the interchangeable shaft assembly shown in FIG. 11 operably coupled to a portion of the surgical instrument of FIG. 1, showing a closure trigger of the surgical instrument in an unactuated position;
FIG. 14 is a right side elevational view of the interchangeable shaft assembly and surgical instrument of FIG. 13;
FIG. 15 is a left side elevational view of the interchangeable shaft assembly and surgical instrument of FIGS. 13 and 14;
FIG. 16 is a perspective view of a portion of the interchangeable shaft assembly shown in FIG. 11 operably coupled to a portion of the surgical instrument of FIG. 1, showing a closure trigger of the surgical instrument in an actuated position and a firing trigger thereof in an unactuated position;
FIG. 17 is a right side elevational view of the interchangeable shaft assembly and surgical instrument of FIG. 16;
FIG. 18 is a left side elevational view of the interchangeable shaft assembly and surgical instrument of FIGS. 16 and 17;
FIG. 18A is a right side elevational view of the interchangeable shaft assembly illustrated in FIG. 11 operably coupled to a portion of the surgical instrument of FIG. 1, showing the closure trigger of the surgical instrument in an actuated position and the firing trigger thereof in an actuated position;
FIG. 19 is a schematic view of a system for powering down an electrical connector of a surgical instrument handle when a shaft assembly is not coupled to the electrical connector;
FIG. 20 is an exploded view of one aspect of an end effector of the surgical instrument of FIG. 1;
FIGS. 21A-21B are circuit diagrams of the surgical instrument of FIG. 1 spanning two sheets of paper;
fig. 22 illustrates an example of a power assembly including a usage cycle circuit configured to generate a usage cycle count for a battery pack;
FIG. 23 illustrates one aspect of a process for sequentially powering up segmented circuits;
FIG. 24 illustrates an aspect of a power section including a plurality of daisy-chained power converters;
FIG. 25 illustrates one aspect of a segmented circuit configured to maximize power available for critical and/or power intensive functions;
FIG. 26 illustrates an aspect of a power system including a plurality of daisy-chained power converters configured to be sequentially energizable;
FIG. 27 illustrates one aspect of a segmented circuit including an isolated control segment;
FIG. 28 (which is divided into FIGS. 28A and 28B) is a circuit diagram of the surgical instrument of FIG. 1;
FIG. 29 is a block diagram of the surgical instrument of FIG. 1 illustrating the interface between the handle assembly 14 and the power assembly, and between the handle assembly 14 and the interchangeable shaft assembly;
FIG. 30 illustrates an exemplary medical device that may include one or more aspects of the present disclosure;
FIG. 31A illustrates an exemplary end effector of a tissue surrounding medical device according to one or more aspects of the present disclosure;
fig. 31B illustrates an example end effector of a medical device compressing tissue according to one or more aspects of the present disclosure;
fig. 32A illustrates an exemplary force applied by an end effector of a medical device compressing tissue according to one or more aspects of the present disclosure;
FIG. 32B also illustrates an exemplary force applied by an end effector of a medical device compressing tissue according to one or more aspects of the present disclosure;
fig. 33 illustrates an exemplary tissue compression sensor system in accordance with one or more aspects of the present disclosure;
fig. 34 also illustrates an exemplary tissue compression sensor system in accordance with one or more aspects of the present disclosure;
fig. 35 also illustrates an exemplary tissue compression sensor system in accordance with one or more aspects of the present disclosure;
fig. 36 illustrates an example end effector channel frame in accordance with one or more aspects of the present disclosure;
FIG. 37 illustrates an example end effector in accordance with one or more aspects of the present disclosure;
Fig. 38 also illustrates an example end effector channel frame in accordance with one or more aspects of the present disclosure;
fig. 39 also illustrates an example end effector channel frame, according to one or more aspects of the present disclosure;
fig. 40 also illustrates an example end effector channel frame, according to one or more aspects of the present disclosure;
fig. 41 illustrates an exemplary electrode according to one or more aspects of the present disclosure;
FIG. 42 illustrates an exemplary electrode wiring system in accordance with one or more aspects of the present disclosure;
fig. 43 also illustrates an example end effector channel frame in accordance with one or more aspects of the present disclosure;
fig. 44 is an exemplary circuit diagram according to one or more aspects of the present disclosure;
fig. 45 is also an exemplary circuit diagram in accordance with one or more aspects of the present disclosure;
FIG. 46 is also an exemplary circuit diagram in accordance with one or more aspects of the present disclosure;
fig. 47 is a graph illustrating an example frequency modulation in accordance with one or more aspects of the present disclosure;
fig. 48 is a graph illustrating a composite RF signal in accordance with one or more aspects of the present disclosure;
fig. 49 is a graph illustrating a filtered RF signal according to one or more aspects of the present disclosure;
FIG. 50 is a perspective view of a surgical instrument having an interchangeable shaft capable of articulation;
FIG. 51 is a side view of the distal end of the surgical instrument illustrated in FIG. 76;
FIGS. 52A-52E are graphs plotting gap size over time (FIG. 52A), firing current over time (FIG. 52B), tissue compression over time (FIG. 52C), anvil strain over time (FIG. 52D), and trigger force over time (FIG. 52E);
FIG. 53 is a graph plotting tissue displacement as a function of tissue compression for normal tissue;
FIG. 54 is a graph plotting tissue displacement as a function of tissue compression for distinguishing normal tissue from diseased tissue; and
FIG. 55 illustrates a cross-sectional view of an end effector of a surgical instrument, according to one aspect.
Description of the invention
The applicant of the present application owns the following patent applications filed on the same day as the present application, each of which is incorporated herein by reference in its entirety:
-U.S. patent application serial No. __________ entitled "POWERED minor instroment"; attorney docket number END7556 USNP/140481;
U.S. patent application Ser. No. __________ entitled "MULTIPLE LEVEL THRESHOLDS TO MODIFY OPERATION OF POWER SURGICAL INSTRUMENTS"; attorney docket number END7552 USNP/140477;
-U.S. patent application Ser. No. __________ entitled "ADAPTIVE TISSUE COMPRESSION TECHNIQUES TO ADAJUST CLOSURE RATES FOR MULTIPLE TISSUE TYPE"; attorney docket number END7557 USNP/140482;
U.S. patent application Ser. No. __________ entitled "MONITORING SPEED CONTROL AND PRECISION INCREASING OF MOTOR FOR POWER SURGICAL INSTRUMENTS"; attorney docket number END7549 USNP/140474;
-U.S. patent application serial No. __________ entitled "INTERACTIVE FEEDBACK SYSTEM FOR POWERED SURGICAL INSTRUMENTS"; attorney docket number END7555 USNP/140480;
U.S. patent application Ser. No. __________ entitled "CONTROL TECHNIQUES AND SUB-PROCESSOR CONTAINED WITHIN MODULAR SHAFT WITH SELECT CONTROL PROCESSING FROM HANDLE"; attorney docket number END7540 USNP/140465;
-U.S. patent application serial No. __________ entitled "SMART SENSORS WITH LOCAL SIGNAL PROCESSING"; attorney docket number END7538 USNP/140463;
-U.S. patent application Ser. No. __________ entitled "SURGICAL INSTRUMENT COMPRISING A LOCKABLE BATTERY HOUSING"; attorney docket number END7548 USNP/140473;
-U.S. patent application Ser. No. __________ entitled "SYSTEM FOR DETECTING THE MIS-INSERTION OF A STAPLE CARTRIDGE INTO A SURGICAL STAPLER"; attorney docket number END7546 USNP/140471; and
-U.S. patent application Ser. No. __________ entitled "SIGNAL AND Power COMMUNICATION SYSTEM POSITIONED ON A ROTATABLE SHAFT"; attorney docket number END7561 USNP/140486.
The applicant of the present application owns the following patent applications filed 2015 on day 2, 27 and each incorporated herein by reference in its entirety:
U.S. patent application Ser. No. 14/633,576 entitled "SURGICAL INSTRUMENT SYSTEM COMPLISING AN INSPECTION STATION";
-U.S. patent application serial No. 14/633,546 entitled "minor applied configuration TO ASSESS WHETHER A minor PARAMETER OF THE minor applied PARAMETER IS WITHIN AN ACCEPTABLE minor PARAMETER BAND";
U.S. patent application Ser. No. 14/633,576 entitled "SURGICAL CHARGING SYSTEM THAT CHARGES AND/OR CONDITIONS ONE OR MORE BATTERIES";
-U.S. patent application serial No. 14/633,566 entitled "CHARGING SYSTEM THAT energy EMERGENCY resolution FOR CHARGING A BATTERY";
-U.S. patent application Ser. No. 14/633,555 entitled "SYSTEM FOR MONITORING WHETHER A SURGICAL INSTRUMENTS NEEDS TO BE SERVICED";
-U.S. patent application serial No. 14/633,542 entitled "related BATTERY FOR a SURGICAL INSTRUMENT";
-U.S. patent application serial No. 14/633,548 entitled "POWER ADAPTER FOR a SURGICAL insert";
-U.S. patent application serial No. 14/633,526 entitled "adaptive minor insert HANDLE";
-U.S. patent application serial No. 14/633,541 entitled "MODULAR station association"; and
U.S. patent application Ser. No. 14/633,562 entitled "SURGICAL APPATUS CONFIGURED TO TRACK AN END-OF-LIFE PARAMETER".
The applicant of the present application owns the following patent applications filed 2014, 12, 18 and each incorporated herein by reference in its entirety:
U.S. patent application Ser. No. 14/574,478 entitled "SURGICAL INSTRUMENT SYSTEM COMPLEMENTS A ARTICULATED END EFFECTOR AND MEANS FOR ADJUSE THE FIRING STROKE OF A FIRING";
U.S. patent application Ser. No. 14/574,483 entitled "SURGICAL INSTRUMENT ASSEMBLY COMPRISING LOCKABLE SYSTEMS";
-U.S. patent application Ser. No. 14/575,139 entitled "DRIVE ARRANGEMENTS FOR ARTICULATABLE SURGICAL INSTRUMENTS";
-U.S. patent application serial No. 14/575,148 entitled "LOCKING argemenets FOR DETACHABLE SHAFT association WITH article END effects";
-U.S. patent application Ser. No. 14/575,130 entitled "SURGICAL INSTRUMENT WITH AN ANVIL THAT IS SELECTIVELY MOVABLE ABOUT A DISCRETE NON-MOVABLE AXIS RELATIVE TO A STAPLE CARTRIDGE";
U.S. patent application Ser. No. 14/575,143 entitled "SURGICAL INSTRUMENTS WITH IMPROVED CLOSURE ARRANGEMENTS";
U.S. patent application Ser. No. 14/575,117 entitled "SURGICAL INSTRUMENTS WITH ARTICULATABLE END EFFECTORS AND MOVABLE FILING BEAM SUPPORT ARRANGEMENTS";
U.S. patent application Ser. No. 14/575,154 entitled "SURGICAL INSTRUMENTS WITH ARTICULATED END EFFECTORS AND IMPROVED FIRING BEAM SUPPORT ARRANGEMENTS";
-U.S. patent application Ser. No. 14/574,493 entitled "SURGICAL INSTRUMENT ASSEMBLY COMPLEMENTING A FLEXIBLE ARTICULATION SYSTEM"; and
U.S. patent application Ser. No. 14/574,500 entitled "SURGICAL INSTRUMENT ASSEMBLY COMPRISING A LOCKABLE ARTICULATION SYSTEM".
The applicant of the present application owns the following patent applications filed on 3/1 of 2013 and each incorporated herein by reference in its entirety:
U.S. patent application Ser. No. 13/782,295 entitled "Integrated Surgical Instruments With reduced Pathways For Signal Communication" (now U.S. patent application publication 2014/0246471);
U.S. patent application Ser. No. 13/782,323 entitled "Rotary Power engineering Joints For scientific Instruments" (now U.S. patent application publication 2014/0246472);
U.S. patent application Ser. No. 13/782,338 entitled "thumb Switch arrays For Surgical Instruments" (now U.S. patent application publication 2014/0249557);
U.S. patent application Ser. No. 13/782,499 entitled "Electrical scientific Device with Signal Relay Arrangement" (now U.S. patent application publication 2014/0246474);
U.S. patent application Ser. No. 13/782,460 entitled "Multiple Processor Motor Control for Modular Surgical Instruments" (now U.S. patent application publication 2014/0246478);
U.S. patent application Ser. No. 13/782,358 entitled "journal Switch Assemblies For Surgical Instruments" (now U.S. patent application publication 2014/0246477);
U.S. patent application Ser. No. 13/782,481 entitled "Sensor straight End Effect During Removal Through Trocar" (now U.S. patent application publication 2014/0246479);
U.S. patent application Ser. No. 13/782,518 entitled "Control Methods for scientific Instruments with Removable implementation procedures" (now U.S. patent application publication 2014/0246475);
U.S. patent application Ser. No. 13/782,375 entitled "road Power Surgical Instruments With Multiple details of Freedom" (now U.S. patent application publication 2014/0246473); and
U.S. patent application Ser. No. 13/782,536 entitled "Surgical Instrument Soft Stop" (now U.S. patent application publication 2014/0246476).
The applicant of the present application also owns the following patent applications filed 2013, month 3, day 14 and each incorporated herein by reference in their entirety:
U.S. patent application Ser. No. 13/803,097 entitled "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING A FIRING DRIVE" (now U.S. patent application publication 2014/0263542);
U.S. patent application Ser. No. 13/803,193 entitled "CONTROL ARRANGEMENTS FOR A DRIVE MEMBER OF A SURGICAL INSTRUMENT" (now U.S. patent application publication 2014/0263537);
U.S. patent application Ser. No. 13/803,053 entitled "INTERCHANGEABLE SHAFT ASSEMBLIES FOR USE WITH A SURGICAL INSTRUMENT" (now U.S. patent application publication 2014/0263564);
U.S. patent application Ser. No. 13/803,086 entitled "ARTICULATABLE SURGICAL INSTRUMENT COMPLISING AN ARTICULATION LOCK" (now U.S. patent application publication 2014/0263541);
U.S. patent application Ser. No. 13/803,210 entitled "SENSOR ARRANGEMENTS FOR ABSOLUTE POSITIONING SYSTEM FOR SURGICAL INSTRUMENTS" (now U.S. patent application publication 2014/0263538);
U.S. patent application Ser. No. 13/803,148 entitled "Multi-functional Motor FOR A SURGICAL INSTRUMENT" (now U.S. patent application publication 2014/0263554);
U.S. patent application Ser. No. 13/803,066 entitled "DRIVE SYSTEM LOCKOUT ARRANGEMENTS FOR MODULAR SURGICAL INSTRUMENTS" (now U.S. patent application publication 2014/0263565);
U.S. patent application Ser. No. 13/803,117 entitled "ARTICULATION CONTROL FOR ARTICULATED SURGICAL INSTRUMENTS" (now U.S. patent application publication 2014/0263553);
U.S. patent application Ser. No. 13/803,130 entitled "DRIVE TRAIN CONTROL ARRANGEMENTS FOR MODULAR SURGICAL INSTRUMENTS" (now U.S. patent application publication 2014/0263543); and
U.S. patent application Ser. No. 13/803,159 entitled "METHOD AND SYSTEM FOR OPERATING A SURGICAL INSTRUMENT" (now U.S. patent application publication 2014/0277017).
The applicant of the present application also owns the following patent applications filed on 3/7/2014 and incorporated herein by reference in their entirety:
U.S. patent application Ser. No. 14/200,111 entitled "CONTROL SYSTEMS FOR SURGICAL INSTRUMENTS" (now U.S. patent application publication 2014/0263539).
The applicant of the present application also owns the following patent applications filed 3/26 2014 and each incorporated herein by reference in its entirety:
U.S. patent application Ser. No. 14/226,106 entitled "POWER MANAGEMENT CONTROL SYSTEM FOR SURGICAL INSTRUMENTS";
-U.S. patent application serial No. 14/226,099 entitled "serilization version CIRCUIT";
-U.S. patent application Ser. No. 14/226,094 entitled "VERIFICATION OF NUMBER OF Battery EXCHANGES/PROCESS COUNT";
U.S. patent application Ser. No. 14/226,117 entitled "POWER MANAGEMENT THROUGH SLEEP OPTIONS OF SEGMENTED CIRCUIT AND WAKE UP CONTROL";
U.S. patent application Ser. No. 14/226,075 entitled "MODULAR POWER SURGICAL INSTRUMENT WITH DETACHABLE SHAFT ASSEMBLIES";
-U.S. patent application Ser. No. 14/226,093 entitled "FEEDBACK ALGORITHMS FOR MANUAL BAILOUT SYSTEMS FOR SURGICAL INSTRUMENTS";
-U.S. patent application serial No. 14/226,116 entitled "SURGICAL INSTRUMENT UTILIZING SENSOR ADAPTATION";
-U.S. patent application serial No. 14/226,071 entitled "SURGICAL INSTRUMENT CONTROL CIRCUIT HAVING A SAFETY PROCESSOR";
-U.S. patent application serial No. 14/226,097 entitled "SURGICAL INSTRUMENT COMPRISING INTERACTIVE SYSTEMS";
-U.S. patent application Ser. No. 14/226,126 entitled "INTERFACE SYSTEMS FOR USE WITH SURGICAL INSTRUMENTS";
-U.S. patent application serial No. 14/226,133 entitled "MODULAR minor injection SYSTEM";
-U.S. patent application serial No. 14/226,081 entitled "SYSTEMS AND METHODS FOR CONTROLLING A SEGMENTED circui";
U.S. patent application Ser. No. 14/226,076 entitled "POWER MANAGEMENT THROUGH SEGMENTED CIRCUIT AND VARIABLE VOLTAGE PROTECTION";
-U.S. patent application serial No. 14/226,111 entitled "SURGICAL STAPLING INSTRUMENTT SYSTEM"; and
U.S. patent application Ser. No. 14/226,125 entitled "SURGICAL INSTRUMENT COMPRISING A ROTATABLE SHAFT".
The applicant of the present application also owns the following patent applications filed on 5/9/2014 and each incorporated herein by reference in its entirety:
-U.S. patent application serial No. 14/479,103 entitled "CIRCUITRY AND SENSORS FOR POWERED MEDICAL DEVICE";
-U.S. patent application Ser. No. 14/479,119 entitled "ADJUNCT WITH INTEGRATED SENSORS TO QUANTIFY TISSUE COMPRESSION";
U.S. patent application Ser. No. 14/478,908 entitled "MONITORING DEVICE DEGRADATION BASED ON COMPONENT EVALUATION";
-U.S. patent application Ser. No. 14/478,895 entitled "MULTIPLE SENSORS WITH ONE SENSOR AFFECTING A SECOND SENSOR' S OUTPUT OR INTERPRETATION";
-U.S. patent application Ser. No. 14/479,110 entitled "USE OF POLARITY OF HALL MAGNET DETECTION TO DETECTION MISLOADED CARTRIDGE";
-U.S. patent application serial No. 14/479,098 entitled "SMART CARTRIDGE WAKE UP OPERATION AND DATA RETENTION";
-U.S. patent application Ser. No. 14/479,115 entitled "MULTIPLE MOTOR CONTROL FOR POWER MEDICAL DEVICE"; and
U.S. patent application Ser. No. 14/479,108 entitled "LOCAL DISPLAY OF TIMSSUE PARAMETER STABILIZATION".
The applicant of the present application also owns the following patent applications filed 2014 on 4/9 and each incorporated herein by reference in its entirety:
U.S. patent application Ser. No. 14/248,590 (now U.S. patent application publication 2014/0305987), entitled "Motor driver minor INSTRUMENTS WITH LOCKABLE DUAL DRIVE SHAFTS";
U.S. patent application Ser. No. 14/248,581 entitled "SURGICAL INSTRUMENT COMPRISING A CLOSING DRIVE AND A FIRING DRIVE OPERATED FROM THE SAME ROTATABLE OUTPUT" (now U.S. patent application publication 2014/0305989);
U.S. patent application Ser. No. 14/248,595 entitled "SURGICAL INSTRUMENT SHAFT INCLUDING SWITCH FOR CONTROLLING THE OPERATION OF THE SURGICAL INSTRUMENT" (now U.S. patent application publication 2014/0305988);
U.S. patent application Ser. No. 14/248,588 entitled "POWER LINEAR SURGICAL STAPLER" (now U.S. patent application publication 2014/0309666);
U.S. patent application Ser. No. 14/248,591 entitled "TRANSMISSION ARRANGEMENT FOR A SURGICAL INSTRUMENT" (now U.S. patent application publication 2014/0305991);
U.S. patent application Ser. No. 14/248,584 (now U.S. patent application publication No. 2014/0305994) entitled "MODULAR MOTOR DRIVEN SURGICAL INSTRUMENTS WITH ALIGNMENT FEATURES FOR ALIGNING ROTARY DRIVE SHAFTS WITH SURGICAL END EFFECTOR SHAFTS";
U.S. patent application serial No. 14/248,587 entitled "POWERED minor platform" (now U.S. patent application publication 2014/0309665);
U.S. patent application Ser. No. 14/248,586 (now U.S. patent application publication 2014/0305990) entitled "DRIVE SYSTEM DECOUPLING ARRANGEMENT FOR A SURGICAL INSTRUMENT"; and
U.S. patent application Ser. No. 14/248,607 entitled "MODULAR MOTOR DRIN SURGICAL INSTRUMENTS WITH STATUS INDICATION ARRANGEMENTS" (now U.S. patent application publication 2014/0305992).
The applicant of the present application also owns the following patent applications filed 2013 on 16.4.2013 and each incorporated herein by reference in its entirety:
U.S. provisional patent application serial No. 61/812,365 entitled "minor entering WITH MULTIPLE functional electronic BY a SINGLE MOTOR";
-U.S. provisional patent application serial No. 61/812,376 entitled "LINEAR CUTTER WITH POWER";
-U.S. provisional patent application serial No. 61/812,382 entitled "LINEAR CUTTER WITH MOTOR AND piston GRIP";
U.S. provisional patent application Ser. No. 61/812,385 entitled "SURGICAL INSTRUMENT HANDLE WITH MULTIPLE ACTION MOTORS AND MOTOR CONTROL"; and
U.S. provisional patent application serial No. 61/812,372 entitled "minor entering WITH MULTIPLE functional PERFORMED BY A SINGLE MOTOR".
The present disclosure provides a complete understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these aspects are illustrated in the accompanying drawings. It will be appreciated by those of ordinary skill in the art that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting examples. Features illustrated or described in connection with one example may be combined with features of other examples. Such modifications and variations are intended to be included within the scope of the present disclosure.
Reference throughout this specification to "various aspects," "some aspects," "one aspect," or "an aspect," etc., means that a particular feature, structure, or characteristic described in connection with the aspect is included in at least one aspect. Thus, appearances of the phrases "in various aspects," "in some aspects," "in one aspect," or "in an aspect," or the like, throughout this specification are not necessarily all referring to the same aspect. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more aspects. Thus, a particular feature, structure, or characteristic shown or described in connection with one aspect may be combined, in whole or in part, with a feature, structure, or characteristic of one or more other aspects, without limitation. Such modifications and variations are intended to be included within the scope of the present disclosure.
The terms "proximal" and "distal" are used herein with respect to a clinician manipulating a handle portion of a surgical instrument. The term "proximal" refers to the portion closest to the clinician and the term "distal" refers to the portion located away from the clinician. It will be further appreciated that for simplicity and clarity, spatial terms such as "vertical," "horizontal," "up," and "down" may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.
Various example devices and methods are provided for performing laparoscopic and minimally invasive surgical procedures. However, one of ordinary skill in the art will readily appreciate that the various methods and devices disclosed herein may be used in a number of surgical procedures and applications, including, for example, in conjunction with open surgery. With continued reference to the present detailed description, those of ordinary skill in the art will further appreciate that the various instruments disclosed herein may be inserted into the body in any manner, such as through a natural orifice, through an incision or puncture formed in tissue, etc. The working portion or end effector portion of the instrument may be inserted directly into the patient or may be inserted through an access device having a working channel through which the end effector and elongate shaft of the surgical instrument may be advanced.
Fig. 1-6 illustrate a reusable or non-reusable motor driven surgical cutting and fastening instrument 10. In the illustrated example, the instrument 10 includes a housing 12 including a handle assembly 14 configured to be grasped, manipulated and actuated by a clinician. The housing 12 is configured for operable attachment to an interchangeable shaft assembly 200 having a surgical end effector 300 operably coupled thereto that is configured to perform one or more surgical tasks or procedures. With continued reference to the present detailed description, it should be understood that the various unique and novel configurations of the various forms of interchangeable shaft assemblies disclosed herein may also be effectively utilized in connection with robotically controlled surgical systems. Thus, the term "housing" may also encompass a housing or similar portion of a robotic system that houses or otherwise operably supports at least one drive system configured to generate and apply at least one control action useful for actuating the interchangeable shaft assemblies disclosed herein and their corresponding equivalents. The term "frame" may refer to a portion of a hand-held surgical instrument. The term "frame" may also represent a portion of a robotically controlled surgical instrument and/or a portion of a robotic system that may be used to operatively control a surgical instrument. For example, the interchangeable shaft assemblies disclosed herein may be used WITH various robotic systems, INSTRUMENTS, components, and methods disclosed in U.S. patent application serial No. 13/118,241 (now U.S. patent application publication No. US 2012/0298719), entitled "SURGICAL INSTRUMENTS WITH rotabable stage design. U.S. patent application Ser. No. 13/118,241 (now U.S. patent application publication US 2012/0298719), entitled "SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS," is hereby incorporated by reference in its entirety.
The housing 12 shown in fig. 1-3 is shown in connection with an interchangeable shaft assembly 200 that includes an end effector 300 that includes a surgical cutting and fastening device configured to operably support a surgical staple cartridge 304 therein. Housing 12 can be configured for use in conjunction with interchangeable shaft assemblies that include end effectors configured to support different sizes and types of staple cartridges, and have different shaft lengths, sizes, types, and the like. Moreover, housing 12 can also be effectively used with a variety of other interchangeable shaft assemblies, including those that are configured to apply other motions and forms of energy (e.g., Radiofrequency (RF) energy, ultrasonic energy, and/or motions) to end effector arrangements that can be used in connection with various surgical applications and procedures. Further, the end effector, shaft assembly, handle, surgical instrument, and/or surgical instrument system may utilize any suitable fastener or fasteners to fasten tissue. For example, a fastener cartridge including a plurality of fasteners removably stored therein can be removably inserted into and/or attached to an end effector of a shaft assembly.
Fig. 1 illustrates a surgical instrument 10 having an interchangeable shaft assembly 200 operably coupled thereto. Fig. 2 and 3 illustrate the attachment of the interchangeable shaft assembly 200 to the housing 12 or handle assembly 14. As shown in fig. 4, the handle assembly 14 may include a pair of interconnectable handle housing segments 16 and 18 that may be interconnected by screws, snap features, adhesives, and the like. In the illustrated construction, the handle housing segments 16, 18 cooperate to form a pistol grip portion 19 that can be grasped and manipulated by a clinician. As will be described in greater detail below, the handle assembly 14 operably supports a plurality of drive systems therein that are configured to generate and apply various control actions to corresponding portions of the interchangeable shaft assembly operably attached thereto.
Referring now to fig. 4, the handle assembly 14 may further include a frame 20 that operably supports a plurality of drive systems. For example, the frame 20 can operably support a "first" or closure drive system, generally designated 30, which can be used to apply closing and opening motions to the interchangeable shaft assembly 200 operably attached or coupled thereto. In at least one form, the closure drive system 30 can include an actuator in the form of a closure trigger 32 pivotally supported by the frame 20. More specifically, as shown in FIG. 4, the closure trigger 32 is pivotably coupled to the housing 14 via a pin 33. Such a configuration allows the closure trigger 32 to be manipulated by the clinician such that when the clinician grasps the pistol grip portion 19 of the handle assembly 14, the closure trigger 32 can be easily pivoted by it from the starting or "unactuated" position to the "actuated" position, and more specifically, to the fully compressed or fully actuated position. The closure trigger 32 may be biased to an unactuated position by a spring or other biasing arrangement (not shown). In various forms, the closure drive system 30 also includes a closure link assembly 34 that is pivotally coupled to the closure trigger 32. As shown in FIG. 4, the closure link assembly 34 may include a first closure link 36 and a second closure link 38 pivotally coupled to the closure trigger 32 by a pin 35. The second closure link 38 may also be referred to herein as an "attachment member" and includes a lateral attachment pin 37.
Still referring to fig. 4, it can be observed that the first closure link 36 can have a locking wall or locking end 39 thereon that is configured to mate with a closure release assembly 60 pivotally coupled to the frame 20. In at least one form, the closure release assembly 60 can include a release button assembly 62 having a distally projecting locking pawl 64 formed thereon. The release button assembly 62 may be pivoted in a counterclockwise direction by a release spring (not shown). When the clinician depresses the closure trigger 32 from its unactuated position toward the pistol grip portion 19 of the handle assembly 14, the first closure link 36 pivots upward to a point where the locking pawl 64 drops into engagement with the locking wall 39 on the first closure link 36, preventing the closure trigger 32 from returning to the unactuated position. See fig. 18. Thus, the closure release assembly 60 functions to lock the closure trigger 32 in the fully actuated position. When the clinician desires to unlock the closure trigger 32 to allow it to be biased to the unactuated position, the clinician need only pivot the closure release button assembly 62 such that the locking pawl 64 moves out of engagement with the locking wall 39 on the first closure link 36. When the locking pawl 64 has moved out of engagement with the first closure link 36, the closure trigger 32 may pivot back to the unactuated position. Other closure trigger locking and release configurations may also be employed.
In addition to the above, fig. 13-15 illustrate the closure trigger 32 in an unactuated position associated with an open or relaxed configuration of the shaft assembly 200 in which tissue may be positioned between the jaws of the shaft assembly 200. Fig. 16-18 illustrate the closure trigger 32 in an actuated position associated with a closed or clamped configuration of the shaft assembly 200 in which tissue is clamped between the jaws of the shaft assembly 200. The reader will appreciate after comparing fig. 14 to fig. 17 that the closure release button 62 pivots between a first position (fig. 14) and a second position (fig. 17) when the closure trigger 32 is moved from its unactuated position (fig. 14) to its actuated position (fig. 17). Rotation of the closure release button 62 may be referred to as upward rotation, however, at least a portion of the closure release button 62 rotates toward the circuit board 100. Referring to fig. 4, the closure release button 62 may include an arm 61 extending therefrom and a magnetic element 63, e.g., a permanent magnet, mounted to the arm 61. When the closure release button 62 is rotated from its first position to its second position, the magnetic element 63 may move toward the circuit board 100. The circuit board 100 may include at least one sensor configured to detect movement of the magnetic element 63. In at least one aspect, the magnetic field sensor 65 may be mounted to a bottom surface of the circuit board 100, for example. The magnetic field sensor 65 may be configured to detect changes in the magnetic field surrounding the magnetic field sensor 65 caused by movement of the magnetic element 63. The magnetic field sensor 65 may, for example, be in signal communication with a microcontroller 1500 (FIG. 19) that can determine whether the closure release button 62 is in its first position associated with the unactuated position of the closure trigger 32 and the open configuration of the end effector, its second position associated with the actuated position of the closure trigger 32 and the closed configuration of the end effector, or any position between the first position and the second position.
As used throughout this disclosure, the magnetic field sensor may be a hall effect sensor, a detection coil, a flux gate, an optical pump, a nuclear spin, a superconducting quantum interferometer (SQUID), a hall effect, an anisotropic magnetoresistance, a giant magnetoresistance, a magnetic tunnel junction, a giant magnetoresistance, a magnetostrictive/piezoelectric composite, a magnetodiode, a magnetotransistor, an optical fiber, a magneto-optical, and a mems-based magnetic sensor, among others.
In at least one form, the handle assembly 14 and the frame 20 can operably support another drive system, referred to herein as a firing drive system 80, that is configured to apply a firing motion to corresponding portions of the interchangeable shaft assembly attached thereto. The firing drive system 80 may also be referred to herein as a "secondary drive system". The firing drive system 80 may employ an electric motor 82 located in the pistol grip portion 19 of the handle assembly 14. In various forms, the motor 82 may be a direct current brushed drive motor having a maximum rotational speed of approximately, for example, 25,000 RPM. In other constructions, the motor may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor 82 may be powered by a power supply 90, which in one form may include a removable power pack 92. As shown in fig. 4, for example, the power pack 92 may include a proximal housing portion 94 configured for attachment to a distal housing portion 96. The proximal housing portion 94 and the distal housing portion 96 are configured to operably support a plurality of batteries 98 therein. Batteries 98 may each include, for example, a lithium ion ("LI") or other suitable battery. The distal housing portion 96 is configured for removable operable attachment to a control circuit board assembly 100 that is also operably coupled to the motor 82. A plurality of batteries 98, which may be connected in series, may be used as a power source for the surgical instrument 10. Further, the power supply 90 may be replaceable and/or rechargeable.
As outlined above with respect to the other various forms, the electric motor 82 may include a rotatable shaft (not shown) operably interfacing with a gear reducer assembly 84 mounted in meshing engagement with a set or rack of drive teeth 122 on the longitudinally movable drive member 120. In use, the polarity of the voltage provided by the power source 90 may operate the electric motor 82 in a clockwise direction, wherein the polarity of the voltage applied by the battery to the electric motor may be reversed to operate the electric motor 82 in a counterclockwise direction. When the electric motor 82 is rotated in one direction, the drive member 120 will be driven axially in the distal direction "DD". When the motor 82 is driven in the opposite rotational direction, the drive member 120 will be driven axially in the proximal direction "PD". The handle assembly 14 may include a switch configured to reverse the polarity applied to the electric motor 82 by the power source 90. As with other versions described herein, the handle assembly 14 may also include a sensor configured to detect the position of the drive member 120 and/or the direction of movement of the drive member 120.
Actuation of the motor 82 may be controlled by a firing trigger 130 pivotally supported on the handle assembly 14. The firing trigger 130 may be pivotable between an unactuated position and an actuated position. The firing trigger 130 may be biased to an unactuated position by a spring 132 or other biasing arrangement such that when the clinician releases the firing trigger 130, the firing trigger may be pivoted or otherwise returned to the unactuated position by the spring 132 or biasing arrangement. In at least one form, the firing trigger 130 can be positioned "outside" the closure trigger 32, as discussed above. In at least one form, the firing trigger safety button 134 may be pivotally mounted to the closure trigger 32 via a pin 35. A safety button 134 may be positioned between the firing trigger 130 and the closure trigger 32 and have a pivoting arm 136 protruding therefrom. See fig. 4. When the closure trigger 32 is in the unactuated position, the safety button 134 is housed within the handle assembly 14 where it may not be easily accessible to the clinician and moved between a safety position preventing actuation of the firing trigger 130 and a firing position in which the firing trigger 130 may be fired. When the clinician depresses the closure trigger 32, the safety button 134 and the firing trigger 130 pivot downward, where they may then be manipulated by the clinician.
As discussed above, the handle assembly 14 may include a closure trigger 32 and a firing trigger 130. Referring to fig. 14-18A, the firing trigger 130 can be pivotally mounted to the closure trigger 32. The closure trigger 32 may include an arm 31 extending therefrom, and the firing trigger 130 may be pivotally mounted to the arm 31 about a pivot pin 33. As outlined above, the firing trigger 130 may descend downwardly as the closure trigger 32 moves from its unactuated position (FIG. 14) to its actuated position (FIG. 17). After the safety button 134 has been moved to its firing position, referring primarily to FIG. 18A, the firing trigger 130 may be depressed to operate the motor of the surgical instrument firing system. In various examples, the handle assembly 14 can include a tracking system, such as the system 800, configured to determine the position of the closure trigger 32 and/or the position of the firing trigger 130. Referring primarily to fig. 14, 17, and 18A, the tracking system 800 may include a magnetic element (e.g., a permanent magnet 802) mounted to an arm 801 extending from the firing trigger 130. The tracking system 800 may include one or more sensors, such as a first magnetic field sensor 803 and a second magnetic field sensor 804, which may be configured to track the position of the magnet 802.
The reader will appreciate after comparing FIG. 14 with FIG. 17 that when the closure trigger 32 is moved from its unactuated position to its actuated position, the magnet 802 is movable between a first position adjacent the first magnetic field sensor 803 and a second position adjacent the second magnetic field sensor 804.
The reader will further appreciate after comparing FIG. 17 with FIG. 18A that the magnet 802 may move relative to the second magnetic field sensor 804 as the firing trigger 130 moves from the unfired position (FIG. 17) to the fired position (FIG. 18A). The sensors 803 and 804 may track the movement of the magnet 802 and may be in signal communication with a microcontroller on the circuit board 100. The microcontroller may determine the position of the magnet 802 along the predefined path using data from the first sensor 803 and/or the second sensor 804, and based on that position, the microcontroller may determine whether the closure trigger 32 is in its unactuated position, its actuated position, or a position between its unactuated position and its actuated position. Similarly, the microcontroller may determine the position of the magnet 802 along the predefined path using data from the first sensor 803 and/or the second sensor 804, and based on that position, the microcontroller may determine whether the firing trigger 130 is in its unfired position, its fully fired position, or a position between its unfired position and its fully fired position.
As mentioned above, in at least one form, the longitudinally movable drive member 120 has a rack of teeth 122 formed thereon for meshing engagement with the corresponding drive gear 86 of the gear reducer assembly 84. At least one form further includes a manually actuatable "panic" assembly 140 configured to allow a clinician to manually retract the longitudinally movable drive member 120 should the motor 82 become deactivated. The emergency assembly 140 may include a lever or emergency handle assembly 14 configured to be manually pivoted into ratcheting engagement with teeth 124 also provided in the drive member 120. Thus, the clinician may manually retract the drive member 120 using the emergency handle assembly 14 to ratchet the drive member 120 in the proximal direction "PD". U.S. patent application publication US 2010/0089970, now U.S. patent 8,608,045, discloses emergency arrangements and other components, arrangements and systems that may also be used with the various instruments disclosed herein. U.S. patent application Ser. No. 12/249,117 (U.S. patent application publication 2010/0089970, now U.S. patent 8,608,045), entitled "POWER SURGICAL CUTTING AND STAPLING APPATUS WITH MANUALLY RETRACTABLE FIRING SYSTEM," is hereby incorporated by reference in its entirety.
Turning now to fig. 1 and 7, the interchangeable shaft assembly 200 includes a surgical end effector 300 that includes an elongate channel 302 configured to operably support a staple cartridge 304 therein. The end effector 300 may also include an anvil 306 that is pivotally supported relative to the elongate channel 302. The interchangeable shaft assembly 200 can further include an articulation joint 270 and an articulation lock 350 (fig. 8) that can be configured to releasably retain the end effector 300 in a desired position relative to the shaft axis SA-SA. Details regarding the construction and operation of end effector 300, ARTICULATION joint 270, and ARTICULATION LOCK 350 are shown in U.S. patent application serial No. 13/803,086 entitled "article subaltern acceleration complex AN ARTICULATION LOCK," filed on 3, 14, 2013 (now U.S. patent application publication 2014/0263541). The entire disclosure of U.S. patent application serial No. 13/803,086 (now U.S. patent application publication 2014/0263541), entitled "article capable of supporting telecommunications AN article selection LOCK," filed on 14/3/2013, is hereby incorporated by reference in its entirety. As shown in fig. 7 and 8, the interchangeable shaft assembly 200 can also include a proximal housing or nozzle 201 comprised of nozzle portions 202 and 203. The interchangeable shaft assembly 200 can also include a closure tube 260 that can be used to close and/or open the anvil 306 of the end effector 300. Referring now primarily to fig. 8 and 9, the shaft assembly 200 may include a ridge 210, which may be configured to fixably support the shaft frame portion 212 of the articulation lock 350. See fig. 8. The ridge 210 may be configured to: a firing member 220 slidably supported therein; two, slidably supports a closure tube 260 that extends around the spine 210. The spine 210 is also configured to slidably support a proximal articulation driver 230. Articulation driver 230 has a distal end 231 configured to operably engage articulation lock 350. The articulation lock 350 interfaces with an articulation frame 352 that is configured to operably engage a drive pin (not shown) on an end effector frame (not shown). As mentioned above, more details regarding the operation of the articulation lock 350 and the articulation frame may be found in U.S. patent application Ser. No. 13/803,086 (now U.S. patent application publication 2014/0263541). In various instances, the spine 210 may include a proximal end 211 rotatably supported in the base 240. In one arrangement, for example, the proximal end 211 of the spine 210 has threads 214 formed thereon for threaded attachment to a spine bearing 216 configured to be supported within the base 240. See fig. 7. This configuration facilitates rotatably attaching the ridge 210 to the base 240 such that the ridge 210 is selectively rotatable relative to the base 240 about the shaft axis SA-SA.
Referring primarily to FIG. 7, the interchangeable shaft assembly 200 includes a closure shuttle 250 slidably supported within the base 240 in an axially movable manner relative thereto. As shown in fig. 3 and 7, the closure shuttle 250 includes a pair of proximally projecting hooks 252 configured to attach to an attachment pin 37 attached to the second closure link 38, as will be discussed in more detail below. The proximal end 261 of the closure tube 260 is coupled to the closure shuttle 250 for rotation relative thereto. For example, the U-shaped connector 263 is inserted into the annular slot 262 in the proximal end 261 of the closure tube 260 such that it remains within the vertical slot 253 in the closure shuttle 250. See fig. 7. Such a configuration is used to attach the closure tube 260 to the closure shuttle 250 for axial travel with the closure shuttle while enabling the closure tube 260 to rotate relative to the closure shuttle 250 about the shaft axis SA-SA. A closure spring 268 is journaled on the closure tube 260 and helps bias the closure tube 260 in the proximal direction "PD" to help pivot the closure trigger into the unactuated position when the shaft assembly is operably coupled to the handle assembly 14.
In at least one form, the interchangeable shaft assembly 200 can further include an articulation joint 270. However, other interchangeable shaft assemblies may not be able to articulate. As shown in FIG. 7, for example, the articulation joint 270 includes a dual pivot closure sleeve assembly 271. According to various forms, the double pivot closure sleeve assembly 271 includes an end effector closure sleeve assembly 272 having distally projecting upper and lower tangs 273, 274. The end effector closure sleeve assembly 272 includes horseshoe apertures 275 and tabs 276 for engaging the open tabs on the anvil 306 in the various manners described in U.S. patent application serial No. 13/803,086 (now U.S. patent application publication 2014/0263541, which is incorporated herein by reference) entitled "article closure insertion a article closure LOCK," filed on 3, 14, 2013. As described in further detail herein, when the anvil 306 is opened, the horseshoe aperture 275 and tab 276 engage the tab on the anvil. The upper dual pivot link 277 includes upwardly projecting distal and proximal pivot pins that engage upper distal pin holes in the upper proximally projecting tang 273 and upper proximal pin holes in the upper distally projecting tang 264, respectively, on the closure tube 260. The lower dual pivot link 278 includes upwardly projecting distal and proximal pivot pins that engage respectively a lower distal pin hole in the proximally projecting inferior tang 274 and a lower proximal pin hole in the distally projecting inferior tang 265. See also fig. 8.
In use, the closure tube 260 is translated distally (direction "DD") to close the anvil 306, for example, in response to actuation of the closure trigger 32. By translating the closure tube 260 distally, and thus the shaft closure sleeve assembly 272, the shaft closure sleeve assembly is caused to impact a proximal surface on the anvil 360, thereby closing the anvil 306, in the manner described in the aforementioned reference U.S. patent application serial No. 13/803,086 (now U.S. patent application publication 2014/0263541). As also detailed in this reference, the anvil 306 is opened by translating the closure tube 260 and shaft closure sleeve assembly 272 proximally, causing the tab 276 and horseshoe aperture 275 to contact and push against the anvil tab to lift the anvil 306. In the anvil open position, the shaft closure tube 260 is moved to its proximal position.
As described above, the surgical instrument 10 may also include an articulation lock 350 of the type and configuration described in more detail in U.S. patent application serial No. 13/803,086 (now U.S. patent application publication 2014/0263541), which may be configured and operable to selectively lock the end effector 300 in place. This configuration enables the end effector 300 to rotate or articulate relative to the shaft closure tube 260 when the articulation lock 350 is in its unlocked state. In this unlocked state, the end effector 300 may be positioned and urged against, for example, soft tissue and/or bone surrounding a surgical site within a patient to articulate the end effector 300 relative to the closure tube 260. The end effector 300 may also be articulated relative to the closure tube 260 by the articulation driver 230.
Also as described above, the interchangeable shaft assembly 200 further includes a firing member 220 that is supported for axial travel within the shaft spine 210. The firing member 220 includes an intermediate firing shaft portion 222 that is configured to be attached to a distal cutting portion or knife bar 280. The firing member 220 may also be referred to herein as a "second shaft" and/or a "second shaft assembly". As shown in fig. 8 and 9, the intermediate firing shaft portion 222 can include a longitudinal slot 223 in a distal end thereof that can be configured to receive a tab 284 on a proximal end 282 of the distal knife bar 280. The longitudinal slot 223 and the proximal end 282 may be sized and configured to allow relative movement therebetween, and may include a slip joint 286. The slip joint 286 can allow the intermediate firing shaft portion 222 of the firing drive 220 to move to articulate the end effector 300 without moving, or at least substantially moving, the knife bar 280. Once the end effector 300 has been properly oriented, the intermediate firing shaft portion 222 can be advanced distally until the proximal side wall of the longitudinal slot 223 contacts the tab 284 in order to advance the knife bar 280 and fire a staple cartridge positioned within the channel 302. As can be further seen in fig. 8 and 9, the shaft spine 210 has an elongated opening or window 213 therein to facilitate assembly and insertion of the intermediate firing shaft portion 222 into the shaft frame 210. Once the intermediate firing shaft portion 222 has been inserted into the shaft frame, the top frame segment 215 may be engaged with the shaft frame 212 to enclose the intermediate firing shaft portion 222 and the knife bar 280 therein. Further description of the operation of the firing member 220 can be found in U.S. patent application serial No. 13/803,086 (now U.S. patent application publication 2014/0263541).
In addition to the above, the shaft assembly 200 can include a clutch assembly 400 that can be configured to selectively and releasably couple the articulation driver 230 to the firing member 220. In one form, the clutch assembly 400 includes a lock collar or lock sleeve 402 positioned about the firing member 220, wherein the lock sleeve 402 is rotatable between an engaged position in which the lock sleeve 402 couples the articulation driver 360 to the firing member 220 and a disengaged position in which the articulation driver 360 is not operably coupled to the firing member 200. When the lock sleeve 402 is in its engaged position, distal movement of the firing member 220 can move the articulation driver 360 distally and, correspondingly, proximal movement of the firing member 220 can move the articulation driver 230 proximally. When the lock sleeve 402 is in its disengaged position, the motion of the firing member 220 is not transferred to the articulation driver 230 and, therefore, the firing member 220 may move independently of the articulation driver 230. In various circumstances, the articulation driver 230 may be held in place by the articulation lock 350 when the articulation driver 230 is not moved in the proximal or distal direction by the firing member 220.
Referring primarily to FIG. 9, the lock sleeve 402 can include a cylindrical or at least substantially cylindrical body including a longitudinal bore 403 defined therein configured to receive the firing member 220. The locking sleeve 402 may include an inwardly facing locking protrusion 404 and an outwardly facing locking member 406, which are diametrically opposed. The lock protrusion 404 can be configured to selectively engage with the firing member 220. More specifically, with the lock sleeve 402 in its engaged position, the lock protrusion 404 is positioned within the drive notch 224 defined in the firing member 220 such that a distal pushing force and/or a proximal pulling force can be transmitted from the firing member 220 to the lock sleeve 402. When the locking sleeve 402 is in its engaged position, the second locking member 406 is received within a drive notch 232 defined in the articulation driver 230 such that a distal pushing force and/or a proximal pulling force applied to the locking sleeve 402 may be transmitted to the articulation driver 230. In fact, when the lock sleeve 402 is in its engaged position, the firing member 220, the lock sleeve 402, and the articulation driver 230 will move together. On the other hand, when the lock sleeve 402 is in its disengaged position, the lock protrusion 404 may not be positioned within the drive notch 224 of the firing member 220, and thus, a distal pushing force and/or a proximal pulling force may not be transmitted from the firing member 220 to the lock sleeve 402. Accordingly, the distal pushing force and/or the proximal pulling force may not be transmitted to the articulation driver 230. In such instances, the firing member 220 can slide proximally and/or distally relative to the lock sleeve 402 and the proximal articulation driver 230.
As shown in fig. 8-12, the shaft assembly 200 further includes a switch drum 500 rotatably received on the closure tube 260. The switch drum 500 includes a hollow shaft segment 502 having a shaft boss 504 formed thereon for receiving the outwardly projecting actuator pin 410 therein. In various circumstances, the actuation pin 410 extends through the slot 267 into a longitudinal slot 408 provided in the locking sleeve 402 to facilitate axial movement of the locking sleeve 402 when engaged with the articulation driver 230. The rotary torsion spring 420 is configured to engage a boss 504 on the switch drum 500 and a portion of the nozzle housing 203 as shown in fig. 10 to apply a biasing force to the switch drum 500. Referring to fig. 5 and 6, the switch drum 500 may further include at least partially circumferential openings 506 defined therein, which may be configured to receive the circumferential mounts 204,205 extending from the nozzle halves 202,203 and allow relative rotation, but not translation, between the switch drum 500 and the proximal nozzle 201. As shown in these figures, the mounts 204 and 205 also extend through openings 266 in the closure tube 260 to seat in the recesses 211 in the shaft ridge 210. However, rotation of the nozzle 201 to a point at which the mounts 204,205 reach the end of their respective slots 506 in the switch drum 500 will cause the switch drum 500 to rotate about the shaft axis SA-SA. Rotation of the switch drum 500 will eventually cause the actuating pin 410 to rotate and cause the locking sleeve 402 to rotate between its engaged and disengaged positions. Thus, in essence, nozzle 201 may be used to operatively engage and disengage an articulation drive system from a firing drive system in a variety of ways as described in more detail in U.S. patent application serial No. 13/803,086 (now U.S. patent application publication 2014/0263541).
As also shown in fig. 8-12, for example, the shaft assembly 200 can include a slip ring assembly 600 that can be configured to conduct electrical power to and/or from the end effector 300 and/or transmit and/or receive signals to and/or from the end effector 300. The slip ring assembly 600 may include a proximal connector flange 604 mounted to a base flange 242 extending from the base 240 and a distal connector flange 601 positioned within a slot defined in the shaft housings 202, 203. The proximal connector flange 604 can comprise a first face and the distal connector flange 601 can comprise a second face, wherein the second face is positioned adjacent to and movable relative to the first face. The distal connector flange 601 is rotatable relative to the proximal connector flange 604 about the shaft axis SA-SA. The proximal connector flange 604 may include a plurality of concentric or at least substantially concentric conductors 602 defined in a first face thereof. Connector 607 may be mounted on a proximal side of connector flange 601 and may have a plurality of contacts (not shown) each corresponding to and in electrical contact with one of conductors 602. This configuration allows for relative rotation between the proximal connector flange 604 and the distal connector flange 601 while maintaining electrical contact therebetween. For example, the proximal connector flange 604 may include an electrical connector 606 that may place the conductor 602 in signal communication with a shaft circuit board 610 mounted to the shaft base 240. In at least one instance, a wire harness including a plurality of conductors can extend between the electrical connector 606 and the shaft circuit board 610. The electrical connector 606 may extend proximally through a connector opening 243 defined in the base mounting flange 242. See fig. 7. U.S. patent application serial No. 13/800,067 (now U.S. patent application publication 2014/0263552), entitled "STAPLE CARTRIDGE TISSUE thicknes SENSOR SYSTEM," filed on 3, 13, 2013, is incorporated by reference in its entirety. U.S. patent application serial No. 13/800,025 (now U.S. patent application publication 2014/0263551), entitled "STAPLE CARTRIDGE TISSUE thicknes SENSOR SYSTEM," filed on 3, 13, 2013, is incorporated by reference in its entirety. More details regarding slip ring assembly 600 may be found in U.S. patent application serial No. 13/803,086 (now U.S. patent application publication 2014/0263541).
As discussed above, the shaft assembly 200 may include a proximal portion that may be fixedly mounted to the handle assembly 14 and a distal portion that may be rotated about a longitudinal axis. As discussed above, the rotatable distal shaft portion may be rotated relative to the proximal portion about the slip ring assembly 600. The distal connector flange 601 of the slip ring assembly 600 may be positioned within the rotatable distal shaft portion. Also, in addition to the above, the switch drum 500 may be positioned within the rotatable distal shaft portion. When the rotatable distal shaft portion is rotated, the distal connector flange 601 and the switch drum 500 can be rotated in synchronization with each other. In addition, the switch drum 500 is rotatable relative to the distal connector flange 601 between a first position and a second position. When the switch drum 500 is in its first position, the articulation drive system may be operably disengaged from the firing drive system, and thus, operation of the firing drive system may not articulate the end effector 300 of the shaft assembly 200. When the switch drum 500 is in its second position, the articulation drive system can be operably engaged with the firing drive system such that operation of the firing drive system can articulate the end effector 300 of the shaft assembly 200. When the switch drum 500 is moved between its first position and its second position, the switch drum 500 is moved relative to the distal connector flange 601. In various instances, the shaft assembly 200 can include at least one sensor configured to detect the position of the switch drum 500. Turning now to fig. 11 and 12, the distal connector flange 601 may comprise, for example, a magnetic field sensor 605, and the switch drum 500 may comprise, for example, a magnetic element, such as permanent magnet 505. Magnetic field sensor 605 may be configured to detect the position of permanent magnet 505. When the switch drum 500 is rotated between its first position and its second position, the permanent magnet 505 may move relative to the magnetic field sensor 605. In various instances, the magnetic field sensor 605 may detect changes in the magnetic field that are generated when the permanent magnet 505 is moved. The magnetic field sensor 605 may be in signal communication with, for example, the shaft circuit board 610 and/or the handle circuit board 100. Based on the signal from the magnetic field 605, a microcontroller on the shaft circuit board 610 and/or the handle circuit board 100 can determine whether the articulation drive system is engaged or disengaged from the firing drive system.
Referring again to fig. 3 and 7, the base 240 includes at least one, and preferably two, tapered attachment portions 244 formed thereon that are receivable within corresponding dovetail slots 702 formed within the distal attachment flange portion 700 of the frame 20. Each dovetail slot 702 may be tapered, or in other words, may be slightly V-shaped, to seatingly receive the attachment portion 244 therein. As can be further seen in fig. 3 and 7, a shaft attachment ear 226 is formed on the proximal end of the intermediate firing shaft 222. As will be discussed in greater detail below, for example, when the interchangeable shaft assembly 200 is coupled to the handle assembly 14, the shaft attachment ears 226 are received in the firing shaft attachment brackets 126 formed in the distal end 125 of the longitudinal drive member 120.
Various shaft assemblies employ a latching system 710 to removably couple the shaft assembly 200 to the housing 12, and more particularly, to the frame 20. As shown in fig. 7, for example, in at least one form, the latch system 710 includes a locking member or locking yoke 712 movably coupled to the base 240. In the illustrated example, for example, the lock yoke 712 is U-shaped having two spaced downwardly extending legs 714. The legs 714 each have a pivot ear 716 formed thereon that is adapted to be received in a corresponding hole 245 formed in the base 240. This configuration facilitates pivotal attachment of the lock yoke 712 to the base 240. The lock yoke 712 may include two proximally projecting lock ears 714 configured to releasably engage with corresponding lock detents or grooves 704 in the distal attachment flange 700 of the frame 20. See fig. 3. In various forms, the lock yoke 712 is biased in a proximal direction by a spring or biasing member (not shown). Actuation of the lock yoke 712 may be accomplished by a latch button 722 slidably mounted on a latch actuator assembly 720 that is mounted to the base 240. The latch button 722 may be biased in a proximal direction relative to the lock yoke 712. As will be discussed in further detail below, the lock yoke 712 may be moved to the unlocked position by biasing the latch button in a distal direction, which also causes the lock yoke 712 to pivot out of retaining engagement with the distal attachment flange 700 of the frame 20. When the lock yoke 712 is "held in engagement" with the distal attachment flange 700 of the frame 20, the lock ears 716 remain seated within the corresponding lock detents or grooves 704 in the distal attachment flange 700.
When interchangeable shaft assemblies are employed that include end effectors of the types described herein as well as other types of end effectors adapted to cut and fasten tissue, it may be advantageous to prevent the interchangeable shaft assemblies from inadvertently disengaging from the housing during actuation of the end effector. For example, in use, a clinician may actuate the closure trigger 32 to grasp and manipulate target tissue to a desired location. Once the target tissue is positioned within the end effector 300 in the desired orientation, the clinician may fully actuate the closure trigger 32 to close the anvil 306 and clamp the target tissue in place for cutting and stapling. In this case, the first drive system 30 has been fully actuated. It may be desirable to prevent the shaft assembly 200 from inadvertently disengaging from the housing 12 after the target tissue has been clamped in the end effector 300. One form of the latching system 710 is configured to prevent such inadvertent disengagement.
As can be seen most particularly in fig. 7, the lock yoke 712 includes at least one and preferably two lock hooks 718 capable of contacting corresponding lock ear portions 256 formed on the closure shuttle 250. Referring to fig. 13-15, when the closure shuttle 250 is in the unactuated position (i.e., the first drive system 30 is unactuated and the anvil 306 is open), the lock yoke 712 can be pivoted in the distal direction to unlock the interchangeable shaft assembly 200 from the housing 12. When in this position, the locking hooks 718 do not contact the locking ear portions 256 on the closure shuttle 250. However, when the closure shuttle 250 is moved to the actuated position (i.e., the first drive system 30 is actuated and the anvil 306 is in the closed position), the lock yoke 712 is prevented from pivoting to the unlocked position. See fig. 16-18. In other words, if the clinician attempts to pivot the lock yoke 712 to the unlocked position, or, for example, the lock yoke 712 is inadvertently bumped or contacted in a manner that might otherwise cause it to pivot distally, the lock hooks 718 on the lock yoke 712 will contact the lock ears 256 on the closure shuttle 250 and prevent the lock yoke 712 from moving to the unlocked position.
Attachment of the interchangeable shaft assembly 200 to the handle assembly 14 will now be described with reference to fig. 3. To begin the coupling process, the clinician may position the base 240 of the interchangeable shaft assembly 200 over or near the distal attachment flange 700 of the frame 20 such that the tapered attachment portion 244 formed on the base 240 aligns with the dovetail slot 702 in the frame 20. The clinician may then move the shaft assembly 200 along a mounting axis IA perpendicular to the shaft axis SA-SA to seat the attachment portions 244 in "operable engagement" with the corresponding dovetail receiving slots 702. In doing so, the shaft attachment ears 226 on the intermediate firing shaft 222 will also be seated in the brackets 126 in the longitudinally movable drive member 120, and the portion of the pin 37 on the second closure link 38 will be seated in the corresponding hook 252 in the closure yoke 250. The term "operably engaged," as used herein in the context of two components, means that the two components are sufficiently engaged with each other such that, upon application of an actuation motion thereto, the components may perform their intended action, function, and/or procedure.
As discussed above, at least five systems of the interchangeable shaft assembly 200 can be operably coupled with at least five corresponding systems of the handle assembly 14. The first system may include a frame system that couples and/or aligns the frame or spine of the shaft assembly 200 with the frame 20 of the handle assembly 14. The second system can include a closure drive system 30 that can operably connect the closure trigger 32 of the handle assembly 14 with the closure tube 260 and anvil 306 of the shaft assembly 200. As outlined above, the closure tube attachment yoke 250 of the shaft assembly 200 may be engaged with the pin 37 on the second closure link 38. Another system may include a firing drive system 80 that may operably connect a firing trigger 130 of the handle assembly 14 with an intermediate firing shaft 222 of the shaft assembly 200.
As outlined above, the shaft attachment ears 226 may be operably connected with the bracket 126 of the longitudinal drive member 120. Another system may include an electrical system that may signal to a controller (e.g., a microcontroller) in the handle assembly 14 that a shaft assembly (e.g., the shaft assembly 200) has been operably engaged with the handle assembly 14 and/or (ii) conduct power and/or communication signals between the shaft assembly 200 and the handle assembly 14. For example, the shaft assembly 200 can include an electrical connector 1410 operably mounted to the shaft circuit board 610. The electrical connector 1410 is configured for mating engagement with a corresponding electrical connector 1400 on the handle control board 100. Further details regarding the circuitry and control system can be found in U.S. patent application serial No. 13/803,086, the entire disclosure of which is previously incorporated herein by reference. The fifth system may consist of a latching system for releasably locking the shaft assembly 200 to the handle assembly 14.
Referring again to fig. 2 and 3, the handle assembly 14 may include an electrical connector 1400 comprising a plurality of electrical contacts. Turning now to fig. 19, the electrical connector 1400 may include, for example, a first contact 1401a, a second contact 1401b, a third contact 1401c, a fourth contact 1401d, a fifth contact 1401e, and a sixth contact 1401 f. Although the illustrated example utilizes six contacts, other examples are contemplated in which more than six contacts or less than six contacts may be utilized.
As shown in fig. 19, the first contact 1401a may be in electrical communication with the transistor 1408, the contacts 1401b-1401e may be in electrical communication with the microcontroller 1500, and the sixth contact 1401f may be in electrical communication with ground. In some cases, one or more of the electrical contacts 1401b-1401e can be in electrical communication with one or more output channels of the microcontroller 1500, and can be energized, or have a voltage potential applied thereto, when the handle 1042 is in a powered state. In some cases, one or more of the electrical contacts 1401b-1401e can be in electrical communication with one or more input channels of the microcontroller 1500, and the microcontroller 1500 can be configured to detect when a voltage potential is applied to such electrical contacts when the handle assembly 14 is in a powered state. When a shaft assembly, such as shaft assembly 200, is assembled to handle assembly 14, electrical contacts 1401a-1401f may not be in communication with each other. However, when the shaft assembly is not assembled to the handle assembly 14, the electrical contacts 1401a-1401f of the electrical connector 1400 may be exposed, and in some cases, one or more of the contacts 1401a-1401f may be accidentally placed in electrical communication with each other. Such a situation may arise, for example, when one or more of the contacts 1401a-1401f contact a conductive material. When this occurs, for example, the microcontroller 1500 can receive the wrong input and/or the shaft assembly 200 can receive the wrong output. To address this issue, in various instances, the handle assembly 14 may not be powered when a shaft assembly, such as the shaft assembly 200, is not attached to the handle assembly 14.
In other instances, the handle 1042 may be charged when a shaft assembly, such as the shaft assembly 200, is not attached to the handle 1042. In this case, for example, the microcontroller 1500 can be configured to ignore inputs or voltage potentials applied to the contacts (i.e., contacts 1401b-1401e) in electrical communication with the microcontroller 1500 until the shaft assembly is attached to the handle assembly 14. The handle assembly 14 may be in a powered down state, although in this case the microcontroller 1500 may be powered to operate other functions of the handle assembly 14. To some extent, electrical connector 1400 can be in a powered down state when the voltage potential applied to electrical contacts 1401b-1401e can not affect the operation of handle assembly 14. The reader will appreciate that even though the contacts 1401b-1401e may be in a powered down state, the electrical contacts 1401a and 1401f that are not in electrical communication with the microcontroller 1500 may or may not be in a powered down state. For example, the sixth contact 4001f can remain in electrical communication with ground whether the handle assembly 14 is in a powered on or powered off state.
Further, whether the handle assembly 14 is in a powered-up or powered-down state, the transistor 1408 and/or any other suitably arranged transistor, such as the transistor 1410 and/or the switch, may be configured to control the supply of power from the power source 1404 (e.g., the battery 90 located within the handle assembly 14) to the first electrical contact 1401 a. In various circumstances, for example, when the shaft assembly 200 is engaged with the handle assembly 14, the shaft assembly 200 can be configured to change the state of the transistor 1408. In some cases, the magnetic field sensor 1402 may be configured to switch the state of the transistor 1410, and thus the state of the transistor 1408, among other things, to ultimately supply power from the power source 1404 to the first contact 1401 a. As such, both the power circuitry and the signal circuitry coupled to the connector 1400 may be powered down when the shaft assembly is not mounted to the handle assembly 14 and powered up when the shaft assembly is mounted to the handle assembly 14.
In various instances, referring again to fig. 19, the handle assembly 14 can include, for example, a magnetic field sensor 1402 that can be configured to detect a detectable element, such as a magnetic element 1407 (fig. 3), located on a shaft assembly, such as the shaft assembly 200, when the shaft assembly is coupled to the handle assembly 14. The magnetic field sensor 1402 may be powered by a power source 1406, such as a battery, which may, in effect, amplify the detection signal of the magnetic field sensor 1402 and communicate with the input channel of the microcontroller 1500 via the circuit shown in FIG. 19. Once the microcontroller 1500 receives an input indicating that the shaft assembly has been at least partially coupled to the handle assembly 14, and thus that the electrical contacts 1401a-1401f are no longer exposed, the microcontroller 1500 can enter its normal or powered operating state. In such an operating state, the microcontroller 1500 will evaluate the signals transmitted from the shaft assembly to one or more of the contacts 1401b-1401e and/or transmit the signals to the shaft assembly through the one or more contacts 1401b-1401e in their normal use state. In various circumstances, it may be necessary to fully seat the shaft assembly 200 before the magnetic field sensor 1402 can detect the magnetic element 1407. For example, while the magnetic field sensor 1402 may be utilized to detect the presence of the shaft assembly 200, any suitable system of sensors and/or switches may be utilized to detect whether the shaft assembly has been assembled to the handle assembly 14. As such, in addition to the above, both the power and signal circuits coupled to the connector 1400 may be powered down when the shaft assembly is not mounted to the handle assembly 14 and powered up when the shaft assembly is mounted to the handle assembly 14.
In various examples, as used throughout this disclosure, any suitable magnetic field sensor may be employed to detect whether a shaft assembly has been assembled to the handle assembly 14, for example. For example, technologies for magnetic field sensing include hall effect sensors, detection coils, flux gates, optical pumps, nuclear spins, superconducting quantum interferometers (SQUIDs), hall effects, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance, magnetostrictive/piezoelectric composites, magnetodiodes, magnetotransistors, optical fibers, magneto-optical, and magnetic sensors based on micro-electromechanical systems, among others.
Referring to fig. 19, microcontroller 1500 can generally include a microprocessor ("processor") and one or more memory units operatively coupled to the processor. The processor, by executing the instruction codes stored in the memory, may control various components of the surgical instrument, such as the motor, various drive systems, and/or a user display. The microcontroller 1500 may be implemented using integrated and/or discrete hardware elements, software elements, and/or a combination of both hardware and software elements. Examples of integrated hardware elements may include processors, microprocessors, microcontrollers, integrated circuits, Application Specific Integrated Circuits (ASICs), Programmable Logic Devices (PLDs), Digital Signal Processors (DSPs), Field Programmable Gate Arrays (FPGAs), logic gates, registers, semiconductor devices, chips, microchips, chip sets, microcontrollers, system-on-chip (SoC), and/or package-on-Systems (SIPs). Examples of discrete hardware elements may include circuits and/or circuit elements, such as logic gates, field effect transistors, bipolar transistors, resistors, capacitors, inductors, and/or relays. In some cases, for example, the microcontroller 1500 may include a hybrid circuit that includes discrete and integrated circuit elements or components on one or more substrates.
Referring to FIG. 19, microcontroller 1500 can be, for example, LM4F230H5QR, available from Texas Instruments. In certain examples, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core, comprising: 256KB of single cycle flash memory or on-chip memory of other non-volatile memory (up to 40MHz), prefetch buffer to improve performance beyond 40MHz, 32KB of single cycle Serial Random Access Memory (SRAM), load with
Figure BDA0001456679220000291
Software internal Read Only Memory (ROM), 2KB Electrically Erasable Programmable Read Only Memory (EEPROM), one or more Pulse Width Modulation (PWM) modules, one or more Quadrature Encoder Input (QEI) analog, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, and other features readily available. Other microcontrollers may be readily substituted for use in conjunction with the present disclosure. Accordingly, the present disclosure should not be limited to this context.
As discussed above, when the shaft assembly 200 is not assembled or not fully assembled to the handle assembly 14, the handle assembly 14 and/or the shaft assembly 200 may comprise systems and configurations configured to prevent or at least reduce the likelihood of shorting of the contacts of the handle electrical connector 1400 and/or the contacts of the shaft electrical connector 1410. Referring to fig. 3, the handle electrical connector 1400 may be at least partially recessed within a cavity 1409 defined in the handle frame 20. The six contacts 1401a-1401f of the electrical connector 1400 may be fully recessed within the cavity 1409. This arrangement may reduce the likelihood of an object accidentally contacting one or more of the contacts 1401a-1401 f. Similarly, the shaft electrical connector 1410 may be positioned within a recess defined in the shaft base 240, which may reduce the likelihood of an object accidentally contacting one or more of the contacts 1411a-1411f of the shaft electrical connector 1410. Referring to the specific example shown in FIG. 3, the shaft contacts 1411a-1411f may comprise male contacts. In at least one example, each shaft contact 1411a-1411f can comprise a flexible tab extending therefrom that can be configured to engage a corresponding handle contact 1401a-1401f, for example. The handle contacts 1401a-1401f may comprise female contacts. In at least one example, each handle contact 1401a-1401f can include a flat surface, for example, against which the axicon contacts 1401a-1401f can wipe or slide and maintain a conductive engagement between the flat surface and the axicon contacts 1401a-1401 f. In various circumstances, the direction of assembly of shaft assembly 200 to handle 14 can be parallel, or at least substantially parallel, to handle contacts 1401a-1401f such that shaft contacts 1411a-1411f slide against handle contacts 1401a-1401f when shaft assembly 200 is assembled to handle assembly 14. In various alternative examples, the handle contacts 1401a-1401f can comprise male contacts and the shaft contacts 1411a-1411f can comprise female contacts. In certain alternative examples, the handle contacts 1401a-1401f and shaft contacts 1411a-1411f can comprise any suitable arrangement of contacts.
In various instances, the handle assembly 14 may include a connector guard configured to at least partially cover the handle electrical connector 1400 and/or a connector guard configured to at least partially cover the shaft electrical connector 1410. The connector guard may prevent, or at least reduce the likelihood of, an object from accidentally contacting the contacts of the electrical connector when the shaft assembly is not assembled, or only partially assembled, to the handle. The connector guard may be movable. For example, the connector guard may be movable between a guarding position, in which the connector guard at least partially protects the connector, and a non-guarding position, in which the connector guard does not protect the connector, or at least provides less protection for the connector. In at least one example, the position of the connector guard may be displaced when assembling the shaft assembly to the handle. For example, if the handle includes a handle connector guard, the shaft assembly may contact and displace the handle connector guard when assembling the shaft assembly to the handle. Similarly, if the shaft assembly includes a shaft connector guard, the handle may contact and displace the shaft connector guard when assembling the shaft assembly to the handle. In various instances, the connector guard may comprise a door, for example. In at least one instance, the door can include a sloped surface that can facilitate displacement of the door in a particular direction when the door is in contact with the handle or shaft. In various circumstances, for example, the connector guard may be translated and/or rotated. In some cases, the connector shield may include at least one film covering the electrical connector contacts. This film may break when the shaft assembly is assembled to the shank. In at least one instance, the male contact of the connector can first pierce the membrane and then engage a corresponding contact positioned below the membrane.
As described above, the surgical instrument can include a system configured to selectively energize or activate contacts of an electrical connector, such as electrical connector 1400. In various instances, the contacts may transition between an inactive condition and an active condition. In some cases, the contacts may transition between a monitoring condition, a deactivation condition, and an activation condition. For example, the microcontroller 1500 may monitor the contacts 1401a-1401f, for example, when the shaft assembly has not been assembled to the handle assembly 14, to determine whether one or more of the contacts 1401a-1401f may have been shorted. The microcontroller 1500 may be configured to apply a low voltage potential to each of the contacts 1401a-1401f and evaluate whether only a minimum resistance is present at each of the contacts. Such operating conditions may include monitoring conditions. If the resistance detected at a contact is high, or exceeds a threshold resistance, microcontroller 1500 can deactivate the contact, more than one contact, or all of the contacts. Such an operating state may include a deactivation condition. As discussed above, if the shaft assembly is assembled to the handle assembly 14 and detected by the microcontroller 1500, the microcontroller 1500 can increase the voltage potential applied to the contacts 1401a-1401 f. Such an operational state may include an active condition.
The various shaft assemblies disclosed herein may employ sensors and various other components that require electrical communication with a controller in the housing. These shaft assemblies are typically configured to be rotatable relative to the housing, and therefore a connection to facilitate such electrical communication must be provided between two or more components that are rotatable relative to one another. When employing an end effector of the type disclosed herein, the connector configuration must be relatively robust in nature, while also being somewhat compact to fit into the connector portion of the shaft assembly.
Referring to FIG. 20, a non-limiting form of an end effector 300 is shown. As described above, the end effector 300 may include an anvil 306 and a staple cartridge 304. In this non-limiting example, an anvil 306 is coupled to the elongate channel 198. For example, an aperture 199 may be defined in the elongate channel 198 that can receive a pin 152 extending from the anvil 306 and allow the anvil 306 to pivot from an open position to a closed position relative to the elongate channel 198 and staple cartridge 304. In addition, fig. 20 illustrates a firing bar 172 that is configured to longitudinally translate into the end effector 300. The firing bar 172 may be constructed of one solid section or, in various examples, may comprise a laminate material including, for example, a stack of steel plates. The distal protruding end of the firing bar 172 may be attached to an E-beam 178 that may (among other things) help space the anvil 306 from the staple cartridge 304 positioned in the elongate channel 198 when the anvil 306 is in the closed position. The E-beam 178 can also include a sharp cutting edge 182, the cutting edge 182 operable to sever tissue as the E-beam 178 is advanced distally through the firing bar 172. In operation, the E-beam 178 can also actuate or fire the staple cartridge 304. The staple cartridge 304 can comprise a molded cartridge body 194 that holds a plurality of staples 191 disposed on staple drivers 192 located in respective upwardly open staple cavities 195. The wedge sled 190 is driven distally by the E-beam 178 to slide over the cartridge tray 196, which holds the various components of the replaceable staple cartridge 304 together. The wedge sled 190 cams staple drivers 192 upward to extrude staples 191 into deforming contact with the anvil 306 while the cutting surface 182 of the E-beam 178 severs clamped tissue.
In addition to the above, the E-beam 178 may include an upper pin 180 that engages the anvil 306 during firing. The E-beam 178 can also include a middle pin 184 and a foot 186 that can engage various portions of the cartridge body 194, the cartridge tray 196, and the elongate channel 198. When the staple cartridge 304 is positioned within the elongate channel 198, the slot 193 defined in the cartridge body 194 can be aligned with the slot 197 defined in the cartridge tray 196 and the slot 189 defined in the elongate channel 198. In use, the E-beam 178 can be slid through the aligned slots 193,197, and 189, as shown in fig. 20, wherein the foot 186 of the E-beam 178 can engage a groove extending along the bottom surface of the channel 198 along the length of the slot 189, the middle pin 184 can engage the top surface of the cartridge tray 196 along the length of the longitudinal slot 197, and the upper pin 180 can engage the anvil 306. In this instance, the E-beam 178 can separate or limit the relative movement between the anvil 306 and the staple cartridge 304 as the firing bar 172 is moved distally to fire the staples from the staple cartridge 304 and/or to cut tissue captured between the anvil 306 and the staple cartridge 304. The firing bar 172 and the E-beam 178 can then be retracted proximally, allowing the anvil 306 to open to release the two stapled and severed tissue portions (not shown).
Having generally described the surgical instrument 10 (fig. 1-4), various electrical/electronic components of the surgical instrument 10 will now be described in detail. Referring now to fig. 21A-21B, one example of a segmented circuit 2000 comprising a plurality of circuit segments 2002a-2002g is shown. The segmented circuit 2000, which includes a plurality of circuit segments 2002a-2002g, is configured to control a powered surgical instrument, such as, but not limited to, the surgical instrument 10 shown in fig. 1-18A. The plurality of circuit segments 2002a-2002g are configured to control one or more operations of the powered surgical instrument 10. The safety processor segment 2002a (segment 1) includes a safety processor 2004. The primary processor segment 2002b (segment 2) includes a primary processor 2006. The safety processor 2004 and/or the primary processor 2006 are configured to interact with one or more additional circuit segments 2002c-2002g to control the operation of the powered surgical instrument 10. The primary processor 2006 includes a plurality of input devices coupled to, for example, one or more circuit segments 2002c-2002g, a battery 2008, and/or a plurality of switches 2058 a-2070. The segmented circuit 2000 may be implemented by any suitable circuit, such as a Printed Circuit Board Assembly (PCBA) within the powered surgical instrument 10. It is to be understood that the term "processor" as used herein includes any kind of microprocessor, microcontroller, or other basic computing device that combines the functions of a computer's Central Processing Unit (CPU) onto one integrated circuit or at most several integrated circuits. A processor is a multipurpose programmable device that receives digital data as input, processes the input according to instructions stored in its memory, and then provides the result as output. A processor is an example of sequential digital logic because it has internal memory. The operands of the processor are numbers and symbols represented in a binary numerical system.
In one aspect, the primary processor 2006 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex, manufactured by Texas Instruments. In one example, the safety processor 2004 may be a safety microcontroller platform comprising two microcontroller-based families, such as TMS570 and RM4x, known under the trade name Hercules ARM Cortex R4, also produced by Texas Instruments. However, other suitable alternatives for the microcontroller and the secure processor may be employed without limitation. In one example, the safety processor 2004 may be specifically configured for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features in delivering quantifiable performance, connectivity, and storage options.
In some cases, the primary processor 2006 may be, for example, LM4F230H5QR, which is available from Texas Instruments. In at least one example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core that includes: 256KB of single cycle flash memory or on-chip memory of other non-volatile memory (up to 40MHz), prefetch buffer to improve performance beyond 40MHz, 32KB of single cycle SRAM, load with
Figure BDA0001456679220000331
Internal ROM of software, EEPROM of 2KB, one or more PWM modules, one or more QEI analog, one or more 12-bit ADC with 12 analog input channels, and other features readily available for production data sheets. Other processors may be readily substituted, and the disclosure should not be limited in this context.
In one aspect, segmented circuit 2000 includes acceleration segment 2002c (segment 3). The acceleration segment 2002c includes an acceleration sensor 2022. The acceleration sensor 2022 may include, for example, an accelerometer. The acceleration sensor 2022 is configured to detect motion or acceleration of the powered surgical instrument 10. In some examples, input from the acceleration sensor 2022 is used to, for example, transition to and from sleep mode, identify the orientation of the powered surgical instrument, and/or identify when the surgical instrument has been dropped. In some examples, the acceleration segment 2002c is coupled to the safety processor 2004 and/or the primary processor 2006.
In one aspect, the segmentation circuit 2000 includes a display segment 2002d (segment 4). The display segment 2002d includes a display connector 2024 coupled to the primary processor 2006. The display connector 2024 couples the primary processor 2006 to a display 2028 through one or more display driver integrated circuits 2026. The display driver integrated circuit 2026 may be integrated with the display 2028 and/or may be located separately from the display 2028. The display 2028 can include any suitable display, such as an Organic Light Emitting Diode (OLED) display, a Liquid Crystal Display (LCD), and/or any other suitable display. In some examples, the display segment 2002d is coupled to the safety processor 2004.
In some aspects, segmented circuit 2000 includes a shaft segment 2002e (segment 5). The shaft segment 2002e comprises one or more controls for coupling to a shaft 2004 of the surgical instrument 10, and/or one or more controls for coupling to an end effector 2006 of the shaft 2004. The shaft segment 2002e comprises a shaft connector 2030 configured to couple the primary processor 2006 to the shaft PCBA 2031. The shaft PCBA 2031 includes a first articulation switch 2036, a second articulation switch 2032, and a shaft PCBA EEPROM 2034. In some examples, the shaft PCBA EEPROM 2034 comprises one or more parameters, routines, and/or programs that are specific to the shaft 2004 and/or the shaft PCBA 2031. The shaft PCBA 2031 may be coupled to the shaft 2004 and/or integral with the surgical instrument 10. In some examples, the shaft segment 2002e comprises a second shaft EEPROM 2038. The second shaft EEPROM 2038 includes a plurality of algorithms, routines, parameters, and/or other data corresponding to one or more shafts 2004 and/or end effectors 2006 that may interface with the powered surgical instrument 10.
In some aspects, the segmented circuit 2000 includes a position encoder segment 2002f (segment 6). The position encoder segment 2002f includes one or more magnetic rotary position encoders 2040a-2040 b. The one or more magnetic rotary position encoders 2040a-2040b are configured to identify the rotary position of the motor 2048, the shaft 2004, and/or the end effector 2006 of the surgical instrument 10. In some examples, the magnetic rotary position encoders 2040a-2040b may be coupled to the safety processor 2004 and/or the primary processor 2006.
In some aspects, the segmented circuit 2000 includes a motor segment 2002g (segment 7). The motor segment 2002g includes a motor 2048 configured to control one or more motions of the powered surgical instrument 10. The motor 2048 is coupled to the primary processor 2006 by an H-bridge driver 2042 and one or more H-bridge Field Effect Transistors (FETs) 2044. The H-bridge FET 2044 is coupled to the safety processor 2004. A motor current sensor 2046 is coupled in series with the motor 2048 for measuring the current draw of the motor 2048. The motor current sensor 2046 is in signal communication with the primary processor 2006 and/or the safety processor 2004. In some examples, the motor 2048 is coupled to a motor electromagnetic interference (EMI) filter 2050.
In some aspects, the segmented circuit 2000 includes a power segment 2002h (segment 8). The battery 2008 is coupled to the safety processor 2004, the primary processor 2006, and one or more of the additional circuit segments 2002c-2002 g. The battery 2008 is coupled to the segmented circuit 2000 by a battery connector 2010 and a current sensor 2012. The current sensor 2012 is configured to measure the total current consumption of the segmented circuit 2000. In some examples, the one or more voltage converters 2014a, 2014b, 2016 are configured to provide predetermined voltage values to the one or more circuit segments 2002a-2002 g. For example, in some examples, the segmented circuit 2000 may include 3.3V voltage converters 2014a-2014b and/or 5V voltage converters 2016. The boost converter 2018 is configured to be capable of providing a boost voltage up to a predetermined amount, such as up to 13V, for example. The boost converter 2018 is configured to provide additional voltage and/or current during power intensive operations and to prevent reduced voltage or low power conditions.
In some aspects, the safety segment 2002a includes a motor power interrupt 2020. The motor power interrupt 2020 is coupled between the power segment 2002h and the motor segment 2002 g. The safety segment 2002a is configured to interrupt power to the motor segment 2002g when the safety processor 2004 and/or the primary processor 2006 detect an error or fault condition, as discussed in greater detail herein. Although the circuit segments 2002a-2002g are shown with all components in the circuit segments 2002a-2002h physically located proximate, one skilled in the art will recognize that the circuit segments 2002a-2002h may include other components that are physically and/or electrically separate from the components of the same circuit segments 2002a-2002 g. In some examples, one or more components may be shared by two or more circuit segments 2002a-2002 g.
In some aspects, a plurality of switches 2056 and 2070 are coupled to the safety processor 2004 and/or the primary processor 2006. The plurality of switches 2056 and 2070 may be configured to control one or more operations of the surgical instrument 10, to control one or more operations of the segmented circuit 2000, and/or to indicate a status of the surgical instrument 10. For example, the panic door switch 2056 is configured to indicate the status of the panic door. A plurality of articulation switches (such as a left articulation switch 2058a, a left right articulation switch 2060a, a left center articulation switch 2062a, a right left articulation switch 2058b, a right center articulation switch 2060b, and a right center articulation switch 2062b) are configured to control articulation of the shaft 2004 and/or the end effector 2006. The left and right reverse switches 2064a and 2064b are coupled to the primary processor 2006. In some examples, left switches (including a left articulation switch 2058a, a left right articulation switch 2060a, a left center articulation switch 2062a, and a left reverse switch 2064a) are coupled to the primary processor 2006 by a left flex connector 2072 a. The right switches (including right left articulation switch 2058b, right articulation switch 2060b, right center articulation switch 2062b, and right reverse switch 2064b) are coupled to the primary processor 2006 by a right flex connector 2072 b. In some examples, a firing switch 2066, a clamp release switch 2068, and a shaft engagement switch 2070 are coupled to the primary processor 2006.
In some aspects, the plurality of switches 2056 and 2070 may comprise, for example, a plurality of handle controls mounted to a handle of the surgical instrument 10, a plurality of indicator switches, and/or any combination thereof. In various examples, the plurality of switches 2056 and 2070 allow the surgeon to manipulate the surgical instrument, provide feedback to the segmented circuit 2000 regarding the position and/or operation of the surgical instrument, and/or indicate unsafe operation of the surgical instrument 10. In some examples, additional or fewer switches can be coupled to the segmented circuit 2000, and one or more of the switches 2056 and 2070 can be combined into a single switch, and/or expanded into multiple switches. For example, in one example, one or more of the left and/or right articulation switches 2058a-2064b may be combined into a single multi-position switch.
In one aspect, the safety processor 2004 is configured to implement a watchdog function, among other safety operations. The safety processor 2004 and the primary processor 2006 of the segmented circuit 2000 are in signal communication. The microprocessor live heartbeat signal is provided at output 2096. The acceleration segment 2002c includes an accelerometer 2022 configured to monitor movement of the surgical instrument 10. In various examples, the accelerometer 2022 may be a single axis, dual axis, or triple axis accelerometer. The accelerometer 2022 may be used to measure appropriate acceleration, which is not necessarily coordinate acceleration (rate of change of velocity). Instead, the accelerometer observes the acceleration associated with the weight phenomenon experienced by the test mass when the frame of reference of the accelerometer 2022 is stationary. For example, an accelerometer 2022 stationary on the surface of the earth will measure a vertical upward (gravitational) acceleration g of 9.8m/s due to its weight 2. Another type of acceleration that the accelerometer 2022 can measure is gravitational acceleration. In various other examples, the accelerometer 2022 may include a single axis, a dual axis, or a triple axis accelerometer. Further, the acceleration segment 2002c may include one or more inertial sensors to detect and measure acceleration, tilt, shock, vibration, rotation, and multiple degrees of freedom (DoF). Suitable inertial sensors may include accelerometers (single, dual or triple axis), magnetometers for measuring spatial magnetic fields, such as the earth's magnetic field, and/or gyroscopes for measuring angular velocity.
In one aspect, the safety processor 2004 is configured to implement a watchdog function with respect to one or more circuit segments 2002c-2002h (e.g., motor segment 2002 g). In this regard, the safety processor 2004 employs a watchdog function to detect and recover from a failure of the primary processor 2006. During normal operation, the safety processor 2004 monitors the primary processor 2004 for hardware faults or program errors and initiates one or more corrective actions. The corrective action may include placing the primary processor 2006 in a safe state and resuming normal system operation. In one example, the safety processor 2004 is coupled to at least a first sensor. The first sensor measures a first property of the surgical instrument 10 (fig. 1-4). In some examples, the safety processor 2004 is configured to compare the measured property of the surgical instrument 10 to a predetermined value. For example, in one example, the motor sensor 2040a is coupled to the safety processor 2004. The motor sensors 2040a provide speed and position information of the motor to the safety processor 2004. The safety processor 2004 monitors the motor sensor 2040a and compares the value to a maximum speed and/or position value, and prevents operation of the motor 2048 if the value is above a predetermined value. In some examples, the predetermined values are calculated based on real-time speed and/or position of the motor 2048, calculated from values provided by the second motor sensor 2040b in communication with the primary processor 2006, and/or provided to the safety processor 2004 from, for example, a memory module coupled to the safety processor 2004.
In some aspects, the second sensor is coupled to the primary processor 2006. The second sensor is configured to measure the first physical property. The safety processor 2004 and the primary processor 2006 are configured to provide signals indicative of the value of the first sensor and the value of the second sensor, respectively. When the safety processor 2004 or the primary processor 2006 indicates a value outside of an acceptable range, the segmented circuit 2000 prevents operation of at least one of the circuit segments 2002c-2002h, such as, for example, the motor segment 2002 g. For example, in the example shown in fig. 21A-21B, the safety processor 2004 is coupled to a first motor position sensor 2040a and the primary processor 2006 is coupled to a second motor position sensor 2040B. The motor position sensors 2040a,2040b may comprise any suitable motor position sensor, for example, a magnetic angular rotational input device having sine and cosine outputs. The motor position sensors 2040a,2040b provide respective signals indicative of the position of the motor 2048 to the safety processor 2004 and the primary processor 2006.
The safety processor 2004 and the primary processor 2006 generate activation signals when the values of the first motor sensor 2040a and the second motor sensor 2040b are within predetermined ranges. When the primary processor 2006 or the safety processor 2004 detects a value outside of a predetermined range, the activation signal is terminated, whereupon operation of at least one of the circuit segments 2002c-2002h (e.g., the motor segment 2002g) is interrupted and/or prevented. For example, in some examples, the activation signal from the primary processor 2006 and the activation signal from the safety processor 2004 are coupled to an and gate. The and gate is coupled to a motor power switch 2020. When the activation signals from both the safety processor 2004 and the primary processor 2006 are high (indicating that the values of the motor sensors 2040a,2040b are within a predetermined range), the and gate maintains the motor power switch 2020 in a closed or open position. When either of the motor sensors 2040a,2040b detects a value outside of a predetermined range, then the activation signals from the motor sensors 2040a,2040b are set low and the output of the and gate is also set low, opening the motor power switch 2020. In some examples, the value of the first sensor 2040a is compared to the value of the second sensor 2040b, for example, by the safety processor 2004 and/or the primary processor 2006. When the value of the first sensor is different from the value of the second sensor, the safety processor 2004 and/or the primary processor 2006 may prevent operation of the motor segment 2002 g.
In some aspects, the safety processor 2004 receives a signal indicative of the value of the second sensor 2040b and compares the value of the second sensor to the value of the first sensor. For example, in one aspect, the safety processor 2004 is coupled directly to the first motor sensor 2040 a. The second motor sensor 2040b is coupled to a primary processor 2006 that provides the value of the second motor sensor 2040b to the safety processor 2004 and/or directly to the safety processor 2004. The safety processor 2004 compares the value of the first motor sensor 2040 with the value of the second motor sensor 2040 b. When the safety processor 2004 detects a mismatch between the first motor sensor 2040a and the second motor sensor 2040b, the safety processor 2004 may interrupt operation of the motor segment 2002g, for example, by cutting power to the motor segment 2002 g.
In some aspects, the safety processor 2004 and/or the primary processor 2006 are coupled to a first sensor 2040a configured to measure a first property of the surgical instrument and a second sensor 2040b configured to measure a second property of the surgical instrument. The first property and the second property comprise a predetermined relationship when the surgical instrument is operating normally. The safety processor 2004 monitors the first property and the second property. A fault is detected when the value of the first property and/or the value of the second property is not in accordance with the predetermined relationship. When a fault occurs, the safety processor 2004 takes at least one action, such as, for example, preventing operation of at least one of the circuit segments, performing a predetermined operation, and/or resetting the primary processor 2006. For example, the safety processor 2004 may open the motor power switch 2020 to cut power to the motor circuit segment 2002g when a fault is detected.
In one aspect, the safety processor 2004 is configured to execute a separate control algorithm. In operation, the safety processor 2004 monitors the segmented circuit 2000 and is configured to independently control and/or override signals from other circuit components, such as the primary processor 2006. The safety processor 2004 may execute preprogrammed algorithms and/or may be updated or programmed online during operation based on one or more actions and/or positions of the surgical instrument 10. For example, in one example, the safety processor 2004 is reprogrammed with new parameters and/or safety algorithms each time a new shaft and/or end effector is coupled to the surgical instrument 10. In some examples, one or more safety values stored by the safety processor 2004 are copied by the primary processor 2006. Bidirectional error detection is performed to ensure that the values and/or parameters stored by the processor 2004 or 2006 are correct.
In some aspects, the safety processor 2004 and the primary processor 2006 implement redundant safety checks. The safety processor 2004 and the primary processor 2006 provide periodic signals indicating normal operation. For example, during operation, the safety processor 2004 may indicate to the primary processor 2006 that the safety processor 2004 is executing code and operating normally. The primary processor 2006 may likewise indicate to the safety processor 2004 that the primary processor 2006 is executing code and operating normally. In some examples, the safety processor 2004 and the primary processor 2006 communicate at predetermined intervals. The predetermined interval may be constant or may vary based on the state of the circuit and/or the operation of the surgical instrument 10.
Fig. 22 illustrates one example of a power assembly 2100 including a usage cycle circuit 2102 configured to monitor a usage cycle count of the power assembly 2100. The power assembly 2100 may be coupled to a surgical instrument 2110. The usage cycle circuit 2102 includes a processor 2104 and a usage indicator 2106. The use indicator 2106 is configured to provide a signal to the processor 2104 to indicate use of the battery pack 2100 and/or a surgical instrument 2110 coupled to the power assembly 2100. "use case" may include any suitable action, condition, and/or parameter, for example, changing modular components of the surgical instrument 2110, deploying or firing disposable components coupled to the surgical instrument 2110, delivering electrosurgical energy from the surgical instrument 2110, repairing the surgical instrument 2110 and/or the power assembly 2100, exchanging the power assembly 2100, recharging the power assembly 2100, and/or exceeding safety limits of the surgical instrument 2110 and/or the battery pack 2100.
In some cases, the usage cycle or usage is defined by one or more power component 2100 parameters. For example, in one case, when power assembly 2100 is at a fully charged level, using a cycle includes using greater than 5% of the total energy available from power assembly 2100. In another case, the usage cycle includes a continuous energy consumption from the power assembly 2100 that exceeds a predetermined time limit. For example, a usage cycle may correspond to five minutes of continuous and/or total energy consumption from power assembly 2100. In some examples, the power assembly 2100 includes a usage cycling circuit 2102 having a continuous power consumption to maintain one or more components of the usage cycling circuit 2102, such as, for example, the usage indicator 2106 and/or the counter 2108, in an active state.
Processor 2104 maintains a usage cycle count. The usage cycle count indicates the number of uses of the power assembly 2100 and/or surgical instrument 2110 detected by the usage indicator 2106. Processor 2104 may increase and/or decrease a usage cycle count based on input from usage indicator 2106. The cycle count is used to control one or more operations of the power assembly 2100 and/or the surgical instrument 2110. For example, in some cases, power component 2100 is disabled when the usage cycle count exceeds a predetermined usage limit. Although the cases described herein are discussed with respect to increasing the usage cycle count beyond a predetermined usage limit, those skilled in the art will recognize that the usage cycle count may begin at some predetermined amount and may be decreased by processor 2104. In this case, the processor 2104 enables and/or prevents one or more operations of the power assembly 2100 when the usage cycle count falls below a predetermined usage limit.
The usage cycle count is maintained by counter 2108. Counter 2108 includes any suitable circuitry, such as a memory module, an analog counter, and/or any circuitry configured to maintain a usage cycle count. In some cases, the counter 2108 is integrally formed with the processor 2104. In other cases, counter 2108 comprises a separate component, such as a solid state memory module. In some cases, the usage cycle count is provided to a remote system, such as a central database. The usage cycle count is transmitted to the remote system by the communication module 2112. The communication module 2112 is configured to be capable of using any suitable communication medium, e.g., wired and/or wireless communication. In some cases, the communication module 2112 is configured to receive one or more instructions, such as a control signal, from a remote system when the usage cycle count exceeds a predetermined usage limit.
In some cases, the usage indicator 2106 is configured to monitor the number of modular components used with the surgical instrument 2110 coupled to the power assembly 2100. The modular components may include, for example, a modular shaft, a modular end effector, and/or any other modular component. In some instances, the usage indicator 2106 monitors usage of one or more disposable components, such as insertion and/or deployment of a staple cartridge within an end effector coupled to the surgical instrument 2110. The usage indicator 2106 includes one or more sensors for detecting the exchange of one or more modular and/or disposable components of the surgical instrument 2110.
In some cases, use indicator 2106 is configured to monitor a single patient surgical procedure performed when power assembly 2100 is installed. For example, the usage indicator 2106 may be configured to monitor the firing of the surgical instrument 2110 when the power assembly 2100 is coupled to the surgical instrument 2110. Firing may correspond to deployment of a staple cartridge, application of electrosurgical energy, and/or any other suitable surgical event. The usage indicator 2106 may include one or more circuits for measuring the number of firings when the power assembly 2100 has been installed. When a single patient procedure is performed, the use indicator 2106 provides a signal to the processor 2104, and the processor 2104 increments a use cycle count.
In some cases, the usage indicator 2106 includes circuitry configured to monitor one or more parameters of the power supply 2114 (e.g., current drawn from the power supply 2114). One or more parameters of the power source 2114 correspond to one or more operations that may be performed by the surgical instrument 2110, such as, for example, cutting and stapling operations. The usage indicator 2106 provides one or more parameters to the processor 2104, which increments the usage cycle count when the one or more parameters indicate that the procedure has been performed.
In some cases, the usage indicator 2106 includes a timing circuit configured to increase a usage cycle count after a predetermined period of time. The predetermined time period corresponds to a single patient procedure time, i.e., the time required for the operator to perform a procedure such as, for example, a cutting and stapling procedure. When the power assembly 2100 is coupled to the surgical instrument 2110, the processor 2104 polls the use indicator 2106 to determine whether the single patient procedure time has ended. When the predetermined time period has elapsed, the processor 2104 increments a usage cycle count. After incrementing the usage cycle count, processor 2104 resets the timing circuitry of user indicator 2106.
In some cases, the use indicator 2106 includes a time constant that approximates the time of a single patient procedure. In one example, the usage cycle circuit 2102 includes a resistor-capacitor (RC) timing circuit 2506. The RC timing circuit includes a time constant defined by a resistor-capacitor pair. The time constant is defined by the values of the resistor and the capacitor. In one example, the usage cycle circuit 2552 includes a rechargeable battery and a clock. When the power assembly 2100 is installed in a surgical instrument, the rechargeable battery is charged by the power source. The rechargeable battery includes sufficient power to run the clock for at least a single patient procedure time. The clock may include a real-time clock, a processor configured to enable timing functions, or any other suitable timing circuitry.
Still referring to fig. 22, in some cases, usage indicator 2106 includes a sensor configured to monitor one or more environmental conditions experienced by power assembly 2100. For example, usage indicator 2106 may include an accelerometer. The accelerometer is configured to monitor acceleration of the power assembly 2100. The power assembly 2100 has a maximum acceleration tolerance. An example of acceleration exceeding a predetermined threshold value is that power component 2100 has been dropped. When the usage indicator 2106 detects that the acceleration exceeds the maximum acceleration tolerance, the processor 2104 increments a usage cycle count. In some cases, usage indicator 2106 includes a moisture sensor. The moisture sensor is configured to indicate when the power assembly 2100 has been exposed to moisture. The moisture sensor may include, for example, an immersion sensor configured to indicate when the power assembly 2100 has been fully immersed in the cleaning fluid, a moisture sensor configured to indicate when moisture contacts the power assembly 2100 during use, and/or any other suitable moisture sensor.
In some cases, usage indicator 2106 comprises a chemical contact sensor. The chemical contact sensor is configured to indicate when the power assembly 2100 has been in contact with a hazardous and/or dangerous chemical. For example, during sterilization, unsuitable chemicals may be used that cause degradation of the power assembly 2100. When the use indicator 2106 detects an unsuitable chemical, the processor 2104 increments a use cycle count.
In some cases, the usage cycling circuit 2102 is configured to monitor the number of repair cycles experienced by the power assembly 2100. The repair cycle may include, for example, a cleaning cycle, a sterilization cycle, a charging cycle, routine and/or preventive maintenance, and/or any other suitable repair cycle. The usage indicator 2106 is configured to detect a repair cycle. For example, the usage indicator 2106 may include a moisture sensor to detect cleaning and/or sterilization cycles. In some cases, the number of repair cycles experienced by the power assembly 2100 is monitored using the cycling circuit 2102 and the power assembly 2100 is disabled after the number of repair cycles exceeds a predetermined threshold.
The usage cycle circuit 2102 may be configured to monitor the number of power assembly 2100 exchanges. The usage cycle circuit 2102 increments a usage cycle count each time the power assembly 2100 is swapped. When the maximum number of exchanges is exceeded, the power assembly 2100 and/or the surgical instrument 2110 are locked out using the cycling circuit 2102. In some cases, when the power assembly 2100 is coupled to the surgical instrument 2110, the usage cycle circuit 2102 identifies the serial number of the power assembly 2100 and locks the power assembly 2100 such that the power assembly 2100 can only be used with the surgical instrument 2110. In some instances, the usage cycle circuit 2102 increases the usage cycle each time the power assembly 2100 is removed from and/or coupled to the surgical instrument 2110.
In some cases, the usage cycle count corresponds to disinfection of the power assembly 2100. The usage indicator 2106 comprises a sensor configured to detect one or more parameters of the sterilization cycle (e.g., a temperature parameter, a chemical parameter, a moisture parameter, and/or any other suitable parameter). When the sterilization parameters are detected, the processor 2104 increments a usage cycle count. After a predetermined number of sterilizations, the power assembly 2100 is deactivated using the cycling circuit 2102. In some examples, the usage cycle circuit 2102 is reset during a sterilization cycle, a voltage sensor, and/or any suitable sensor detection recharge cycle. When a repair loop is detected, the processor 2104 increments a usage loop count. When a sterilization cycle is detected, the usage cycle circuit 2102 is disabled. The usage cycle circuit 2102 is reactivated and/or reset when the power assembly 2100 is coupled to the surgical instrument 2110. In some cases, the usage indicator includes a zero power indicator. The zero power indicator changes state during the sterilization cycle and is checked by the processor 2104 when the power assembly 2100 is coupled to the surgical instrument 2110. When the zero power indicator indicates that a sterilization cycle has occurred, processor 2104 increments a usage cycle count.
Counter 2108 keeps the usage cycle count. In some cases, counter 2108 comprises a non-volatile memory module. Whenever a usage cycle is detected, the processor 2104 increments a usage cycle count stored in the non-volatile memory module. The memory module is accessible by the processor 2104 and/or control circuitry (e.g., control circuitry 200). When the usage cycle count exceeds a predetermined threshold, the processor 2104 disables the power component 2100. In some cases, the usage cycle count is maintained by a plurality of circuit components. For example, in one case, the counter 2108 comprises a bank of resistors (or fuses). After each use of the power assembly 2100, the resistors (or fuses) may be blown into an open position, thereby changing the resistance of the resistor bank. The power assembly 2100 and/or the surgical instrument 2110 read the remaining resistance values. When the last resistor of the resistor bank is burned out, the resistor bank has a predetermined resistance such as, for example, an infinite resistance corresponding to an open circuit, indicating that the power assembly 2100 has reached its limit of use. In some cases, the resistance of the resistor bank is used to derive the remaining number of uses.
In some cases, the usage cycle circuit 2102 prevents further use of the power assembly 2100 and/or the surgical instrument 2110 when the usage cycle count exceeds a predetermined usage limit. In one case, the usage cycle count associated with the power assembly 2100 is provided to the operator, for example, using a screen integrally formed with the surgical instrument 2110. The surgical instrument 2110 provides an indication to the operator that the usage cycle count has exceeded a predetermined limit of the power assembly 2100 and prevents further operation of the surgical instrument 2110.
In some cases, the usage cycle circuit 2102 is configured to physically prevent operation thereof when a predetermined usage limit is reached. For example, the power assembly 2100 may include a shroud configured to be deployed over the contacts of the power assembly 2100 when the usage cycle count exceeds a predetermined usage limit. The shroud prevents recharging and use of power assembly 2100 by covering the electrical connections of power assembly 2100.
In some cases, the usage cycle circuit 2102 is at least partially located within the surgical instrument 2110 and is configured to maintain a usage cycle count of the surgical instrument 2110. FIG. 22 illustrates, in phantom, one or more components of a usage cycling circuit 2102 within a surgical instrument 2110 and illustrates an alternative positioning of the usage cycling circuit 2102. The usage cycle circuit 2102 deactivates and/or prevents operation of the surgical instrument 2110 when a predetermined usage limit of the surgical instrument 2110 is exceeded. When the use indicator 2106 detects a particular event and/or need (e.g., firing of the surgical instrument 2110, a predetermined time period corresponding to a single patient procedure time), the use cycle circuit 2102 increments the use cycle count according to one or more motor parameters of the surgical instrument 2110 in response to the system diagnostic indicating that one or more predetermined thresholds have been reached and/or any other suitable need has been met. As discussed above, in some examples, the use indicator 2106 includes a timing circuit corresponding to a single patient procedure time. In other instances, the usage indicator 2106 includes one or more sensors configured to detect particular events and/or conditions of the surgical instrument 2110.
In some examples, the usage cycle circuit 2102 is configured to prevent use of the surgical instrument 2110 after a predetermined usage limit is reached. In some cases, the surgical instrument 2110 includes a visual indicator to indicate when a predetermined use limit has been reached and/or exceeded. For example, a marking (such as a red marking) may be ejected from the surgical instrument 2110 (such as from the handle) to provide a visual indication to the operator that the surgical instrument 2110 has exceeded a predetermined use limit. As another example, the usage cycle circuit 2102 can be coupled to a display that is integrally formed with the surgical instrument 2110. The usage cycle circuit 2102 displays information indicating that a predetermined usage limit has been exceeded. The surgical instrument 2110 may provide an audible indication to the operator that a predetermined usage limit has been exceeded. For example, in one instance, when a predetermined usage limit is exceeded, the surgical instrument 2110 emits an audible tone and the power assembly 2100 is then removed from the surgical instrument 2110. The audible tone indicates the last use of the surgical instrument 2110 and indicates that the surgical instrument 2110 should be discarded or repaired.
In some cases, the usage cycle circuit 2102 is configured to transmit the usage cycle count of the surgical instrument 2110 to a remote location, e.g., a central database. The usage cycle circuit 2102 includes a communication module 2112 configured to transmit the usage cycle count to a remote location. The communication module 2112 may utilize any suitable communication system, such as a wired and/or wireless communication system. The remote location may include a central database configured to maintain usage information. In some cases, when the power assembly 2100 is coupled to the surgical instrument 2110, the power assembly 2100 records the serial number of the surgical instrument 2110. For example, when the power assembly 2100 is coupled to a charger, the serial number is transmitted to a central database. In some examples, the central database maintains a count corresponding to each use of the surgical instrument 2110. For example, each time the surgical instrument 2110 is used, a barcode associated with the surgical instrument 2110 may be scanned. When the usage count exceeds a predetermined usage limit, the central database provides a signal to the surgical instrument 2110 indicating that the surgical instrument 2110 should be discarded.
The surgical instrument 2110 can be configured to lock out and/or prevent operation of the surgical instrument 2110 when the usage cycle count exceeds a predetermined usage limit. In some cases, the surgical instrument 2110 comprises a disposable instrument and is discarded after the usage cycle count exceeds a predetermined usage limit. In other instances, the surgical instrument 2110 comprises a reusable surgical instrument that can be reconditioned after a usage cycle count exceeds a predetermined usage limit. The surgical instrument 2110 initiates reversible lockout after a predetermined limit of use is reached. The technician repairs the surgical instrument 2110 and releases the latch, for example, using a technical key configured to reset the usage cycle circuit 2102.
In some aspects, the segmented circuit 2000 is configured to be sequentially enabled. Error checking is performed by each circuit segment 2002a-2002g before power is applied to the next circuit segment 2002a-2002g in the sequence. Fig. 23 shows one example of a process for sequentially powering up segmented circuit 2270, e.g., segmented circuit 2000. When the battery 2008 is coupled to the segmented circuit 2000, the safety processor 2004 powers up 2272. The safety processor 2004 performs an error self test 2274. When an error is detected 2276a, the secure processor stops powering on the segmented circuit 2000 and generates an error code 2278 a. When no error is detected 2276b, the safety processor 2004 begins to power up the primary processor 2006 2278 b. The primary processor 2006 performs an error self-check. When no errors are detected, the primary processor 2006 begins sequentially powering up 2278b each of the remaining circuit segments. The primary processor 2006 performs power-on and error checking for each circuit segment. When no error is detected, the next circuit segment is energized 2278 b. When an error is detected, the safety processor 2004 and/or the primary processor stops energizing the current segment and generates an error 2278 a. Sequential activation continues until the circuit segments 2002a-2002g have all been energized. In some examples, the segmented circuit 2000 transitions from the sleep mode after a similar sequential power-up process 11250.
Fig. 24 illustrates an aspect of a power segment 2302 that includes a plurality of daisy-chained power converters 2314, 2316, 2318. The power segment 2302 includes a battery 2308. The battery 2308 is configured to provide a source voltage, such as 12V. A current sensor 2312 is coupled to the battery 2308 to monitor the current draw of the segmented circuit and/or one or more circuit segments. The current sensor 2312 is coupled to an FET switch 2313. The battery 2308 is coupled to one or more voltage converters 2309, 2314, 2316. The always-on converter 2309 provides a constant voltage to one or more circuit components, such as the motion sensor 2322. The always-on converter 2309 includes, for example, a 3.3V converter. The always-on converter 2309 may provide a constant voltage to additional circuit components, such as a safety processor (not shown). The battery 2308 is coupled to a boost converter 2318. The boost converter 2318 is configured to provide a boosted voltage greater than that provided by the battery 2308. For example, in the illustrated example, the battery 2308 provides 12V. The boost converter 2318 is configured to boost a voltage to 13V. The boost converter 2318 is configured to maintain a minimum voltage during operation of a surgical instrument, such as, for example, the surgical instrument 10 (fig. 1-4). Operation of the motor may cause the power provided to the primary processor 2306 to drop below a minimum threshold and create a voltage drop or reset condition in the primary processor 2306. The boost converter 2318 ensures that sufficient power is available to the primary processor 2306 and/or other circuit components, such as the motor controller 2343, during operation of the surgical instrument 10. In some examples, the boost converter 2318 is coupled directly to one or more circuit components, such as an OLED display 2388.
The boost converter 2318 is coupled to one or more buck converters to provide a voltage below the boost voltage level. The first voltage converter 2316 is coupled to the boost converter 2318 and provides a reduced voltage to one or more circuit components. In the example shown, the first voltage converter 2316 provides a voltage of 5V. The first voltage converter 2316 is coupled to a rotary position encoder 2340. The FET switch 2317 is coupled between the first voltage converter 2316 and the rotary position encoder 2340. The FET switch 2317 is controlled by the processor 2306. The processor 2306 opens the FET switch 2317 to deactivate the position encoder 2340, for example, during power intensive operations. The first voltage converter 2316 is coupled to a second voltage converter 2314, which is configured to provide a second reduced voltage. The second reduced voltage includes, for example, a voltage of 3.3V. The second voltage converter 2314 is coupled to the processor 2306. In some examples, the boost converter 2318, the first voltage converter 2316, and the second voltage converter 2314 are coupled in a daisy-chain configuration. The daisy-chain configuration allows the use of smaller and more efficient converters for generating voltage levels lower than the boosted voltage level. However, these examples are not limited to the particular voltage ranges described in the context of this specification.
Fig. 25 illustrates an aspect of a segmented circuit 2400 that is configured to maximize power available for critical functions and/or power intensive functions. The segmented circuit 2400 includes a battery 2408. The battery 2408 is configured to provide a source voltage, such as 12V. The source voltage is provided to a plurality of voltage converters 2409, 2418. The always-on voltage converter 2409 provides a constant voltage to one or more circuit components, such as the motion sensor 2422 and the safety processor 2404. The always-on voltage converter 2409 is coupled directly to the battery 2408. The always-on voltage converter 2409 provides a voltage of, for example, 3.3V. However, these examples are not limited to the particular voltage ranges described in the context of this specification.
The segmented circuit 2400 includes a boost converter 2418. The boost converter 2418 provides a boosted voltage that is greater than the source voltage (e.g., 13V) provided by the battery 2408. The boost converter 2418 provides a boosted voltage directly to one or more circuit components, such as the OLED display 2488 and the motor controller 2443. By coupling the OLED display 2488 directly to the boost converter 2418, the segmented circuit 2400 eliminates the need for a power converter dedicated to the OLED display 2488. The boost converter 2418 provides a boosted voltage to the motor controller 2443 and the motor 2448 during one or more power intensive operations of the motor 2448, such as a cutting operation. The boost converter 2418 is coupled to the buck converter 2416. The buck converter 2416 is configured to provide a voltage (e.g., 5V) lower than the boosted voltage to one or more circuit components. The buck converter 2416 is coupled to, for example, a FET switch 2451 and a position encoder 2440. The FET switch 2451 is coupled to the main processor 2406. When the segmented circuit 2400 transitions to the sleep mode, and/or during power intensive functions requiring additional voltage to be delivered to the motor 2448, the main processor 2406 turns off the FET switch 2451. Opening the FET switch 2451 deactivates the position encoder 2440 and eliminates power consumption by the position encoder 2440. However, these examples are not limited to the particular voltage ranges described in the context of this specification.
The buck converter 2416 is coupled to the linear converter 2414. The linear converter 2414 is configured to provide a voltage of, for example, 3.3V. The linear converter 2414 is coupled to the primary processor 2406. The linear converter 2414 provides an operating voltage to the main processor 2406. The linear converter 2414 may be coupled to one or more additional circuit components. However, these examples are not limited to the particular voltage ranges described in the context of this specification.
The segmented circuit 2400 includes an emergency switch 2456. The panic switch 2456 is coupled to a panic door on the surgical instrument 10. Emergency switch 2456 and safety processor 2404 are coupled to an and gate 2419. And gate 2419 provides an input to FET switch 2413. When the panic switch 2456 detects a panic condition, the panic switch 2456 provides a panic close signal to the and gate 2419. When security processor 2404 detects an unsafe condition, e.g., due to a sensor mismatch, security processor 2404 provides a close signal to and gate 2419. In some examples, both the emergency shutdown signal and the shutdown signal are high during normal operation and low when a reduced voltage condition or an unsafe condition is detected. When the output of and gate 2419 is low, FET switch 2413 is open and operation of motor 2448 is prevented. In some examples, secure processor 2404 transitions motor 2448 to an off state in sleep mode with an off signal. A third input is provided to the FET switch 2413 by a current sensor 2412 coupled to the battery 2408. The current sensor 2412 monitors the current drawn by the circuit 2400 and, when it is detected that the current is greater than a predetermined threshold, opens the FET switch 2413 to shut off power to the motor 2448. The FET switch 2413 and motor controller 2443 are coupled to a set of FET switches 2445 configured to control operation of the motor 2448.
The motor current sensor 2446 is coupled in series with the motor 2448 to provide a motor current sensor reading to the current monitor 2447. The current monitor 2447 is coupled to the main processor 2406. The current monitor 2447 provides a signal indicative of the current draw of the motor 2448. The main processor 2406 may utilize signals from the motor current monitor 2447 to control operation of the motor, e.g., to ensure that the current draw of the motor 2448 is within an acceptable range, to compare the current draw of the motor 2448 to one or more other parameters of the circuit 2400 (such as the position encoder 2440), and/or to determine one or more parameters of the treatment site. In some examples, a current monitor 2447 can be coupled to the safety processor 2404.
In some aspects, actuation of one or more handle controls, such as a firing trigger, causes the main processor 2406 to reduce power to one or more components when the handle controls are actuated. For example, in one example, a firing trigger controls the firing stroke of the cutting member. The cutting member is driven by a motor 2448. Actuation of the firing trigger causes forward operation of the motor 2448 and advancement of the cutting member. During firing, the main processor 2406 closes the FET switch 2451 to remove power from the position encoder 2440. Deactivation of one or more circuit components allows higher power to be delivered to motor 2448. When the firing trigger is released, full power is restored to the deactivated feature, for example, by closing the FET switch 2451 and reactivating the position encoder 2440.
In some aspects, secure processor 2404 controls the operation of segmented circuit 2400. For example, secure processor 2404 may initiate sequential power-up of segmented circuit 2400, transitions of segmented circuit 2400 into and out of sleep mode, and/or may override one or more control signals from main processor 2406. For example, in the example shown, the safety processor 2404 is coupled to a buck converter 2416. The secure processor 2404 controls the operation of the segmented circuit 2400 by activating or deactivating the buck converter 2416 to provide power to the rest of the segmented circuit 2400.
Fig. 26 illustrates one aspect of a power system 2500 that includes a plurality of daisy-chained power converters 2514, 2516, 2518 configured to be sequentially energized. The plurality of daisy-chained power converters 2514, 2516, 2518 may be sequentially activated by, for example, a security processor during initial power up and/or transition from sleep mode. The safety processor may be powered by a separate power converter (not shown). For example, in one example, when the battery voltage VBATTCoupled to power system 2500 and/or acceleratedWhen the meter detects movement in sleep mode, the safety processor triggers the sequential activation of the daisy-chained power converters 2514, 2516, 2518. The security processor activates the 13V boost section 2518. The boost section 2518 is powered on and performs a self test. In some examples, the boost section 2518 includes an integrated circuit 2520 configured to boost the source voltage and perform self-testing. The diode D prevents the 5V supply section 2516 from powering up until the boost section 2518 has completed self-checking and provided a signal to the diode D indicating that the boost section 2518 did not identify any errors. In some examples, the signal is provided by a secure processor. However, these examples are not limited to the particular voltage ranges described in the context of this specification.
The 5V supply section 2516 is sequentially powered up after the boost section 2518. The 5V power section 2516 performs a self test during power up to identify any errors in the 5V power section 2516. The 5V power supply section 2516 includes an integrated circuit 2515 configured to be able to provide a reduced voltage from a boosted voltage and to be able to perform error checking. When no error is detected, the 5V power section 2516 completes the sequential power up and provides an activation signal to the 3.3V power section 2514. In some examples, the security processor provides an activation signal to the 3.3V power supply segment 2514. The 3.3V power section includes an integrated circuit 2513 configured to be able to provide a reduced voltage from the 5V power section 2516 and to perform error self-checking during power-up. When no errors are detected during the self-test, the 3.3V power supply segment 2514 provides power to the main processor. The primary processor is configured to sequentially energize each of the remaining circuit segments. By sequentially energizing the power system 2500 and/or the remainder of the segmented circuit, the power system 2500 reduces the risk of errors, achieves voltage level stability before applying a load, and prevents all hardware from being turned on simultaneously in an uncontrolled manner resulting in large current consumption. However, these examples are not limited to the particular voltage ranges described in the context of this specification.
In one aspect, the power system 2500 includes an over-voltage identification and mitigation circuit. The overvoltage identification and mitigation circuit is configured to detect a monopolar return current in the surgical instrument and interrupt power from the power section when the monopolar return current is detected. The overvoltage identification and mitigation circuit is configured to identify a ground float of the power system. The overvoltage identification and mitigation circuit includes a metal oxide varistor. The overvoltage identification and reduction circuit includes at least one transient voltage suppression diode.
Fig. 27 illustrates an aspect of segmented circuit 2600 that includes a single point control segment 2602. Single point control segment 2602 isolates the control hardware of segmented circuit 2600 from the power segments (not shown) of segmented circuit 2600. The control section 2602 includes, for example, a main processor 2606, a safety processor (not shown), and/or additional control hardware (e.g., FET switch 2617). The power section includes, for example, a motor driver, and/or a plurality of motor MOSFETs. The single point control segment 2602 includes a charging circuit 2603 and a rechargeable battery 2608 coupled to a 5V power converter 2616. The charging circuit 2603 and rechargeable battery 2608 isolate the main processor 2606 from the power segment. In some examples, the rechargeable battery 2608 is coupled to the safety processor and any additional support hardware. Isolating the control segment 2602 from the power segment allows the control segment 2602 (e.g., the main processor 2606) to remain active (even when the main power supply is removed), provide a filter through the rechargeable battery 2608 to keep noise away from the control segment 2602, isolate the control segment 2602 from drastic changes in the battery voltage to ensure proper operation (even during large motor loads), and/or allow a real-time operating system (RTOS) to be used by the segmentation circuit 2600. In some examples, the rechargeable battery 2608 provides a reduced voltage, e.g., a voltage of 3.3V, to the main processor. However, these examples are not limited to the particular voltage ranges described in the context of this specification.
Fig. 28A and 28B illustrate another aspect of the control circuit 3000 configured to control the powered surgical instrument 10 of fig. 1-18A. As shown in fig. 18A, 28B, the handle assembly 14 may include a motor 3014 that may be controlled by a motor driver 3015 and used by the firing system of the surgical instrument 10. In various forms, the motor 3014 may be a dc brushed driving motor having a maximum rotational speed of approximately, for example, 25,000 RPM. In other constructions, the motor 3014 may comprise a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. In some cases, the motor driver 3015 may include, for example, an H-bridge FET 3019, as shown in fig. 28A and 28B. The motor 3014 may be powered by a power assembly 3006 that is releasably mountable to the handle assembly 14. The power assembly 3006 is configured to supply control power to the surgical instrument 10. The power assembly 3006 may include a battery that may include a plurality of battery cells connected in series that may be used as a power source to power the surgical instrument 10. In this configuration, the power assembly 3006 may be referred to as a battery pack. In some cases, the battery cells of the power assembly 3006 may be replaceable and/or rechargeable. In at least one example, the battery cell can be a lithium ion battery that can be detachably coupled to the power assembly 3006.
An example OF a drive SYSTEM and closure SYSTEM suitable for use with SURGICAL INSTRUMENT 10 is disclosed in U.S. provisional patent application serial No. 61/782,866 entitled "CONTROL SYSTEM OF a SURGICAL INSTRUMENT" filed on 3, 14, 2013, the entire disclosure OF which is incorporated herein by reference in its entirety. For example, the electric motor 3014 may include a rotatable shaft (not shown) operatively connected to a gear reducer assembly that is mounted on a longitudinally movable drive member in meshing engagement with the drive teeth of a set or rack of gears. In use, the polarity of the voltage provided by the battery may operate the electric motor 3014 to drive the longitudinally movable drive member to effect the end effector 300. For example, the motor 3014 can be configured to drive a longitudinally movable drive member to advance a firing mechanism to fire staples from a staple cartridge assembled with the end effector 300 into tissue captured by the end effector 300 and/or to advance a cutting member to, for example, cut tissue captured by the end effector 300.
As shown in fig. 28A and 28B and described in more detail below, for example, the power assembly 3006 can include a power management controller that can be configured to adjust the power output of the power assembly 3006 so as to deliver a first power output to energize the motor 3014 to advance the cutting member when the interchangeable shaft assembly 200 is coupled to the handle assembly 14 (fig. 1) and so as to deliver a second power output to energize the motor 3014 to advance the second cutting member when the interchangeable shaft assembly 200 is coupled to the handle assembly 14. Such adjustment may be advantageous in avoiding transmission of excessive power to the motor 3014 beyond the requirements of the interchangeable shaft assembly coupled to the handle assembly 14.
In certain instances, the interface 3024 may facilitate the transfer of one or more communication signals between the power management controller 3016 and the shaft assembly controller 3022, for example, by routing such communication signals through a main controller 3017 located in the handle assembly 14 (fig. 1). In other instances, when the shaft assembly 200 (fig. 1) and the power assembly 3006 are coupled to the handle assembly 14, the interface 3024 may facilitate direct communication lines between the power management controller 3016 and the shaft assembly controller 3022 through the handle assembly 14.
In one case, main microcontroller 3017 may be any type of single-core or multi-core processor, such as those known under the trade name ARM Cortex, manufactured by Texas Instruments. In one example, the surgical instrument 10 (fig. 1-4) may include a power management controller 3016, e.g., a safety microcontroller platform including two microcontroller-based families, such as TMS570 and RM4x, also available from Texas Instruments under the trade name Hercules ARM Cortex R4. However, other suitable alternatives for the microcontroller and the secure processor may be employed without limitation. In one case, the safety processor 2004 (fig. 21A) may be specifically configured for IEC 61508 and ISO 26262 safety critical applications, and the like, to provide advanced integrated safety features in delivering quantifiable performance, connectivity, and storage options.
In some cases, microcontroller 3017 may be, for example, LM4F230H5QR, which is commercially available from Texas Instruments. In at least one example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core including 256KB single cycle flash memory up to 40MHz or other non-volatile memory on-chip memory, a prefetch buffer above 40MHz for improved performance, 32KB single cycle Serial Random Access Memory (SRAM), loaded with DRAM, and the like
Figure BDA0001456679220000501
Software built-in Read Only Memory (ROM), 2KB Electrically Erasable Programmable Read Only Memory (EEPROM), one or more Pulse Width Modulation (PWM) modules, one or more Quadrature Encoder Input (QEI) analog, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, and other features that are readily available to a product data sheet. The present disclosure should not be limited in this context.
Fig. 29 is a block diagram of the surgical instrument of fig. 1 illustrating the interface between the handle assembly 14 (fig. 1) and the power assembly, and between the handle assembly 14 and the interchangeable shaft assembly. As shown in fig. 29, the power component 3006 may include a power management circuit 3034, which may include a power management controller 3016, a power modulator 3038, and a current sensing circuit 3036. The power management circuit 3034 may be configured to regulate the power output of the battery 3007 based on the power requirements of the shaft assembly 200 (fig. 1) when the shaft assembly 200 and the power assembly 3006 are coupled to the handle assembly 14. For example, the power management controller 3016 may be programmed to control the power modulator 3038 to regulate the power output of the power component 3006, and the current sensing circuit 3036 may be used to monitor the power output of the power component 3006 to provide feedback to the power management controller 3016 regarding the power output of the battery 3007 so that the power management controller 3016 can regulate the power output of the power component 3006 to maintain a desired output.
Notably, the power management controller 3016 and/or the axle assembly controller 3022 may each include one or more processors and/or memory units that may store a plurality of software modules. Although certain modules and/or blocks of the surgical instrument 14 (fig. 1) may be described by way of example, it should be understood that a greater or lesser number of modules and/or blocks may be used. In addition, although various aspects may be described in terms of modules and/or blocks for ease of illustration, the modules and/or blocks may be implemented by one or more hardware components (e.g., processors, Digital Signal Processors (DSPs), Programmable Logic Devices (PLDs), Application Specific Integrated Circuits (ASICs), circuits, registers) and/or software components (e.g., programs, subroutines, logic), and/or a combination of hardware and software components.
In certain examples, the surgical instrument 10 (fig. 1-4) may include an output device 3042 that may include one or more devices for providing sensory feedback to a user. Such devices may include, for example, visual feedback devices (e.g., LCD display screens, LED indicators), audible feedback devices (e.g., speakers, buzzers), or tactile feedback devices (e.g., haptic actuators). In some instances, the output device 3042 may include a display 3043, which may be included in the handle assembly 14 (fig. 1). Shaft assembly controller 3022 and/or power management controller 3016 may provide feedback to a user of surgical instrument 10 via output devices 3042. The interface 3024 may be configured to connect the shaft assembly controller 3022 and/or the power management controller 3016 to the output device 3042. The reader will appreciate that output devices 3042 can alternatively be integrated with power components 3006. In such instances, when the shaft assembly 200 is coupled to the handle assembly 14, communication between the output device 3042 and the shaft assembly controller 3022 may be enabled through the interface 3024.
Having now described the surgical instrument 10 (fig. 1-4) and the various control circuits 2000,3000 for controlling the operation of the surgical instrument, various specific configurations of the surgical instrument 10 and control circuit 2000 (or 3000) will be described.
In various aspects, the present disclosure provides an instrument 10 (described in connection with fig. 1-29) configured to sense tissue compression when tissue is clamped between jaw members of an end effector (such as, for example, between an anvil and a staple cartridge). In one example, instrument 10 (fig. 1-4) may be configured to sense tissue contact in one of the jaw members (e.g., such as an anvil and/or staple cartridge). As another example, instrument 10 can be configured to sense pressure applied to tissue by the jaw members. As another example, instrument 10 can be configured to measure an electrical impedance (resistance) through tissue between the jaw members. This can be achieved by: a microelectrode is embedded within at least one of the jaw members to drive a low amplitude, low energy RF signal through the tissue, thereby causing a non-therapeutic measurement of tissue impedance. The energy level is kept low enough to avoid therapeutic tissue effects such as coagulation, sealing, welding, or cauterization. Further, instrument 10 may include means to generate two different measurements from a single set of power-on and return paths. In one example, multiple frequency signals may be superimposed to measure impedance in different locations simultaneously. This may include a single movable electrode with the channel and anvil grounded through an isolated path with filters for different frequency RF signals. Otherwise, two isolated return paths with independent filters as part of the handle electronics system may be used. As another example, sequential impedance measurements may be multiplexed at variable RF frequencies.
RF technology has been used in endoscopic cutters for some time. The challenge with this technique is related to the delivery of high density RF energy and short circuiting between the jaw members of the end effector. Despite the therapeutic shortcomings of using RF energy, RF technology can be used subtherapeutically effectively to sense tissue compression rather than actually coagulate, seal, or cauterize tissue. In a sub-therapeutic sense, endoscopic surgical devices may employ RF energy to sense internal tissue parameters and adjust staple deployment, rather than being used as an aid to the stapling operation to seal tissue prior to cutting the tissue with a knife.
RF technology used in endoscopic surgical medical devices (e.g., RF endocutters) can introduce challenges to handle high energy densities and to handle short circuits. However, there may be less challenges if RF technology is used only to sense tissue compression rather than, for example, cauterizing tissue. RF technology may be used in medical devices such as endocutters to sense internal tissue parameters (such as compression) and in response adjust suture deployment. The RF electrode and cauterization device may use the same electrode to sense tissue impedance while melting tissue. These same electrodes can be implemented as tissue compression sensor systems based on significantly lower electrical and power requirements.
The RF electrode and cautery device may sense tissue impedance using the same electrode when welding tissue by applying energy to the tissue. However, in the context of an endoscopic cutter instrument, the RF electrode may be used as a tissue compression sensor system with significantly lower electronic and power requirements relative to a fully assembled electrosurgical device. A single powered electrode, such as on a cartridge or possibly a separate knife, may be used to perform multiple tissue compression measurements simultaneously. If multiple RF signals are superimposed or multiplexed, they may be transmitted along a single power conductor and allowed to return to the channel frame or anvil of the device. If the filter is disposed within the anvil and channel contacts before they are switched into the common return path, the tissue impedance for both paths can be differentiated. This will provide a measure of compression through the tissue relative to the lateral tissue. The filtering method may be implemented proximally and distally, rather than vertically and laterally, depending on the placement of the filter and the location of the metallic conductive return path. Smaller frequency generators and signal processors can be implemented on existing circuit boards or daughter circuit boards in small package sizes without the substantial additional cost associated with RF seal cauterization systems.
Referring to fig. 30, endocutter 6000 can comprise a handle component 6002, a shaft component 6004, and an end effector component 6006. The endocutter 6000 is constructed and arranged similarly to the motor-driven surgical cutting and fastening instrument 10 described in connection with FIGS. 1-29. Accordingly, for the sake of brevity and clarity, details of operation and construction will not be repeated here. The end effector 6006 may be used to compress, cut, or staple tissue. Referring now to fig. 31A, the end effector 6030 can be positioned by the clinician to encompass tissue 6032 prior to compression, cutting or stapling. As shown in fig. 31A, when the end effector is ready for use, no compression may be applied to the tissue. Referring now to fig. 31B, by engaging the handle of the endocutter (e.g., handle 6002), the physician can use the end effector 6030 to compress tissue 6032. In one aspect, the tissue 6032 may be compressed to its maximum threshold, as shown in fig. 31B.
Referring to fig. 32A, various forces can be applied to the tissue 6032 by the end effector 6030. For example, when the tissue 6032 is compressed between the anvil 6034 and the channel frame 6036 of the end effector 6030, vertical forces F1 and F2 may be applied through both. Referring now to fig. 32B, as the tissue 6032 is compressed by the end effector 6030, various diagonal and/or lateral forces can also be applied to the tissue. For example, force F3 may be applied. For the purpose of operating a medical device, such as endocutter 6000, it may be desirable to sense or calculate various forms of compression applied to tissue by the end effector. For example, the indication of vertical or lateral compression may allow the end effector to more accurately or more precisely apply a stapling operation, or may inform the operator of the endocutter so that the endocutter may be more correctly or safely used.
The compression through the tissue 6032 can be determined from the impedance of the tissue 6032. At various levels of compression, the impedance Z of the tissue 6032 can increase or decrease. By applying the voltage V and current I to the tissue 6032, the impedance Z of the tissue 6032 at various compression levels can be determined. For example, the impedance Z may be calculated by dividing the applied voltage V by the current I.
Referring now to fig. 33, in one aspect, the RF electrode 6038 can be positioned on the end effector 6030 (e.g., on a staple cartridge, on a knife, or on a channel frame of the end effector 6030). Further, the electrical contacts 6040 can be positioned on an anvil 6034 of the end effector 6030. In one aspect, the electrical contacts can be positioned on a channel frame of the end effector. As the tissue 6032 is compressed between the anvil 6034 and, for example, the channel frame 6036 of the end effector 6030, the impedance Z of the tissue 6032 changes. The vertical tissue compression 6042 caused by the end effector 6030 can be measured as a function of the impedance Z of the tissue 6032.
Referring now to fig. 34, in one aspect, the electrical contacts 6044 can be positioned on an opposite end of the anvil 6034 of the end effector 6030 from where the RF electrodes 6038 are positioned. As the tissue 6032 is compressed between the anvil 6034 and, for example, the channel frame 6036 of the end effector 6030, the impedance Z of the tissue 6032 changes. The lateral tissue compression 6046 caused by the end effector 6030 can be measured as a function of the impedance Z of the tissue 6032.
Referring now to fig. 35, in one aspect, the electrical contacts 6050 can be positioned on the anvil 6034 and the electrical contacts 6052 can be positioned on the opposite end of the end effector 6030 at the channel frame 6036. The RF electrode 6048 can be positioned laterally with respect to the center of the end effector 6030. As the tissue 6032 is compressed between the anvil 6034 and, for example, the channel frame 6036 of the end effector 6030, the impedance Z of the tissue 6032 changes. Lateral or angular compressions 6054 and 6056 on either side of the RF electrode 6048 can be caused by the end effector 6030 and can be measured as a function of different impedances Z of the tissue 6032 based on the relative positioning of the RF electrode 6048 and the electrical contacts 6050 and 6052.
In accordance with one or more of the techniques and features described in this disclosure, and as discussed above, the RF electrode may be used as an RF sensor. Referring now to FIG. 36, in one aspect, an RF sensor 6062 can be positioned on a staple cartridge 6060 inserted into a channel frame 6066 of the end effector. The RF electrode can extend from a power line 6064, which can be powered by a power source in the handle of the endocutter (e.g., handle 6002).
Referring now to FIG. 37, in one aspect, RF electrodes 6074 and 6076 can be positioned on a staple cartridge 6072 that is inserted into a channel frame 6078 of an end effector 6070. As shown, the RF electrode 6074 can be placed in a proximal position of the end effector relative to the endocutter handle. Further, the RF electrode 6076 can be placed in a distal position of the end effector relative to the endocutter handle. RF electrodes 6074 and 6076 can be used to measure vertical, lateral, proximal, or distal compression at different points in tissue depending on the position of one or more electrical contacts on the end effector.
Referring now to FIG. 38, in one aspect, the RF electrodes 6084 and 6116 can be positioned on the staple cartridge 6082 inserted into the channel frame 6080 (or other component of the end effector) based on the various points at which compression information is desired. Referring now to FIG. 39, in one aspect, the RF electrodes 6122 and 6140 can be positioned on the staple cartridge 6120 at discrete points where compression information is desired. Referring now to FIG. 40, RF electrodes 6152 and 6172 may be positioned at different points in multiple regions of the staple cartridge based on how the compression measurements should be accurate or precise. For example, the RF electrodes 6152 and 6156 can be positioned in the region 6158 of the staple cartridge 6150 in a manner that should be accurate or precise based on the compression measurements in the region 6158. In addition, the RF electrodes 6160-6164 can be positioned in the region 6166 of the staple cartridge 6150 in a manner that should be accurate or precise based on the compression measurements in the region 6166. In addition, the RF electrodes 6168-6172 can be positioned in the region 6174 of the staple cartridge 6150 in a manner that should be accurate or precise based on the compression measurements in the region 6174.
The RF electrodes discussed herein may be wired through a staple cartridge inserted into the channel frame. Referring now to fig. 41, in one aspect, the RF electrode can have an embossed "mushroom head" 6180 of about 1.0mm in diameter. While the RF electrode may have an embossed "mushroom head" with a diameter of about 1.0mm, this is intended to be a non-limiting example and the RF electrode may have different shapes and sizes depending on each particular application or design. The RF electrode can be connected to, secured to, or can form conductive wire 6182. The conductive wire 182 may have a diameter of about 0.5mm, or may have a larger or smaller diameter based on the particular application or design. Furthermore, the conductive wire may have an insulating coating 6184. In one example, the RF electrode can protrude through a staple cartridge, channel frame, knife, or other component of the end effector.
Referring now to fig. 42, the RF electrodes can be wired through a single wall or multiple walls of a staple cartridge or channel frame of the end effector. For example, the RF electrodes 6190 and 6194 can be wired through a wall 6196 of the staple cartridge or channel frame of the end effector. One or more of wires 6198 can be connected to, secured to, or part of RF electrode 6190, 6194, and can extend through wall 6196 from a power source in the handle of the endocutter, for example.
Referring now to FIG. 43, a power source can be in communication with the RF electrode, or power can be supplied to the RF electrode via a wire or cable. A wire or cable may join each individual wire and lead to a power source. For example, the RF electrode 6204 and 6212 can receive power from a power source via a wire or cable 6202 that can extend through the staple cartridge 6200 or channel frame of the end effector. In one example, each RF electrode 6204-6212 may have its own wire running up to or through wire or cable 6202. The staple cartridge 6200 or channel frame may also include a controller 6214, such as in conjunction with controller 2006 shown in fig. 21A, 21B, or in conjunction with other controllers 2606 or 3017 shown in fig. 27-29. It should be appreciated that the controller 6214 can be sized to fit within the staple cartridge 6200 or channel frame. In addition, the controller
In various aspects, a tissue compression sensor system for use with a medical device described herein can include a frequency generator. The frequency generator may be located on a circuit board of a medical device, such as an endocutter. For example, the frequency generator may be located on a circuit board in the shaft or handle of the endocutter. Referring now to fig. 44, an example circuit diagram 6220 is shown in accordance with one example of the present disclosure. As shown, the frequency generator 6222 can receive power or current from a power source 6221 and can provide one or more RF signals to one or more RF electrodes 6224. As discussed above, one or more RF electrodes can be positioned at various locations or components (such as a staple cartridge or channel frame) on the end effector or endocutter. One or more electrical contacts, such as electrical contact 6226 or 6228, can be positioned on the channel frame or anvil of the end effector. Further, one or more filters, such as filters 6230 or 6232, can be communicatively coupled to the electrical contacts 6226 or 6228, as shown in fig. 44. The filters 6230 and 6232 may filter one or more RF signals provided by the frequency generator 6222 before they are coupled into a single return path 6234. The voltage V and current I associated with the one or more RF signals can be used to calculate an impedance Z associated with tissue that is compressible and/or communicatively coupled between the one or more RF electrodes 6224 and the electrical contacts 6226 or 6228.
Referring now to fig. 45, the various components of the tissue compression sensor systems described herein can be located in a handle 6236 of an endocutter. For example, as shown in the circuit diagram 6220a, the frequency generator 6222 can be located in the handle 6236 and can receive power from the power source 6221. Additionally, current I1 and current I2 may be measured on return paths corresponding to electrical contacts 6228 and 6226. With the voltage V applied between the supply path and the return path, the impedances Z1 and Z2 can be calculated. Z1 can correspond to an impedance of tissue compressed and/or communicably coupled between one or more RF electrodes 6224 and electrical contacts 6228. Further, Z2 can correspond to an impedance of tissue compressed and/or communicably coupled between the one or more RF electrodes 6224 and the electrical contacts 6226. Applying the formulas Z1-V/I1 and Z2-V/I2, impedances Z1 and Z2 corresponding to different levels of compression of tissue compressed by the end effector can be calculated.
Referring now to fig. 46, one or more aspects of the present disclosure are described in a circuit diagram 6250. In a particular implementation, a power source at the handle 6252 of the endocutter can provide power to the frequency generator 6254. The frequency generator 6254 may generate one or more RF signals. One or more RF signals can be multiplexed or superimposed at a multiplexer 6256, which can be located in the endocutter shaft 6258. In this way, two or more RF signals may be superimposed (or nested or modulated together, for example) and transmitted to the end effector. The one or more RF signals can energize one or more RF electrodes 6260 (e.g., positioned in a staple cartridge) at the end effector 6262 of the endoscope cutter. Tissue (not shown) can be compressible and/or can be communicatively coupled between the one or more RF electrodes 6260 and the one or more electrical contacts. For example, tissue can be compressible and/or can be communicably coupled between the one or more RF electrodes 6260 and the electrical contacts 6264 positioned in the channel frame of the end effector 6262 or the electrical contacts 6266 positioned in the anvil of the end effector 6262. The filter 6268 can be communicatively coupled to the electrical contact 6264 and the filter 6270 can be communicatively coupled to the electrical contact 6266.
The voltage V and current I associated with the one or more RF signals can be used to calculate an impedance Z associated with tissue that is compressible between the staple cartridge (and which can be communicably coupled to the one or more RF electrodes 6260) and the channel frame or anvil (and which can be communicably coupled to the one or more electrical contacts 6264 or 6266).
In one aspect, the various components of the tissue compression sensor systems described herein can be located in the shaft 6258 of the endocutter. For example, as shown in the circuit diagram 6250 (and in addition to the frequency generator 6254), the impedance calculator 6272, the controller 6274, the non-volatile memory 6276, and the communication channel 6278 may be located in the shaft 6258. In one example, the frequency generator 6254, the impedance calculator 6272, the controller 6274, the non-volatile memory 6276, and the communication channel 6278 may be located on a circuit board in the shaft 6258.
Two or more RF signals may be returned on a common path via the electrical contacts. Further, two or more RF signals may be filtered to distinguish individual tissue impedances represented by the two or more RF signals prior to joining the RF signals on the common path. Current I1 and current I2 can be measured on the return paths corresponding to electrical contacts 6264 and 6266. With the voltage V applied between the supply path and the return path, the impedances Z1 and Z2 can be calculated. Z1 can correspond to an impedance of tissue compressed and/or communicably coupled between one or more RF electrodes 6260 and electrical contacts 6264. Further, Z2 can correspond to an impedance of tissue compressed and/or communicably coupled between one or more RF electrodes 6260 and electrical contacts 6266. Applying the formulas Z1-V/I1 and Z2-V/I2, impedances Z1 and Z2 corresponding to the different compressions of the tissue compressed by the end effector 6262 can be calculated. In this example, impedances Z1 and Z2 may be calculated by an impedance calculator 6272. The different compression levels of the tissue can be calculated using the impedances Z1 and Z2.
Referring now to fig. 47, a frequency plot 6290 is shown. The frequency plot 6290 illustrates frequency modulation to nest two RF signals. As described above, the two RF signals can be nested before reaching the RF electrode at the end effector. For example, an RF signal having a frequency 1 and an RF signal having a frequency 2 may be nested together. Referring now to fig. 48, the resulting nested RF signal is shown in frequency plot 6300. The composite signal shown in frequency plot 6300 comprises two RF signals of frequency plot 6290 combined together. Referring now to fig. 49, a frequency plot 6310 is shown. Frequency plot 6310 shows the RF signal after filtering (through, for example, filters 6268 and 6270) having frequencies 1 and 2. The resulting RF signal may be used to make a separate impedance calculation or measurement on the return path, as described above.
In one aspect, the filters 6268 and 6270 may be high-quality factor (Q) filters such that the filter range may be narrow-band (e.g., Q-10). Q may be defined by a center frequency (Wo)/Bandwidth (BW), where Q ═ Wo/BW. In one example, frequency 1 may be 150kHz and frequency 2 may be 300 kHz. An effective impedance measurement range may be 100 kHz-20 MHz. In various examples, other complex techniques (such as correlation, quadrature detection, etc.) may be utilized to separate the RF signals.
Utilizing one or more of the techniques and features described herein, a single powered electrode on a staple cartridge or a separation knife of an end effector may be used to simultaneously make multiple tissue compression measurements. If two or more RF signals are superimposed or multiplexed (or nested or modulated), they may be transmitted along a single power side of the end effector and may be returned on the channel frame or anvil of the end effector. If the filter is built into the anvil and channel contacts before they are switched into a common return path, the tissue impedance represented by the two paths can be differentiated. This can provide a measure of compression of the vertical tissue relative to the lateral tissue. The method may also provide proximal and distal tissue compression depending on the placement of the filter and the location of the metal return path. The frequency generator and signal processor may be located on one or more chips on a circuit board or daughter board (which may already be present in the endocutter).
The present disclosure will now be described in conjunction with various embodiments and combinations of such embodiments, which are set forth below.
1. One embodiment provides a tissue compression sensor system comprising: an RF electrode positioned on an end effector; a first electrical contact positioned on one of an anvil or a channel frame of the end effector; and a first filter that may be communicably coupled to the first electrical contact.
2. Another embodiment provides the tissue compression sensor system of embodiment 1, further comprising: a second electrical contact positioned on one of the anvil or the channel frame of the end effector; and a second filter that may be communicably coupled to the second electrical contact.
3. Another embodiment provides the tissue compression sensor system of embodiment 2, further comprising: a multiplexer configured to transmit two or more RF signals to the end effector.
4. Another embodiment provides the compression sensor system of embodiment 2 or 3, wherein the first and second electrical contacts open into a common return path.
5. Another embodiment provides the tissue compression sensor system of embodiment 3 or 4, wherein the RF signal is transmitted along a single power side of the end effector.
6. Another embodiment provides the tissue compression sensor system of any one of embodiments 2-5, further comprising: an impedance calculator in communication with the first filter and the second filter.
7. Another embodiment provides the tissue compression sensor system of any one of embodiments 3-6, further comprising: a frequency generator configured to generate two or more RF signals.
8. Another embodiment provides the tissue compression sensor system of any one of embodiments 1-7, wherein the RF electrode is positioned on a staple cartridge of the end effector.
9. Another embodiment provides the tissue compression sensor system of any one of embodiments 1-8, further comprising: a plurality of RF electrodes positioned at discrete points on the end effector.
10. Another embodiment provides the tissue compression sensor system of any one of embodiments 1-9, further comprising: a plurality of RF electrodes positioned in a plurality of regions on the end effector.
11. Another embodiment provides a method for sensing tissue compression, the method comprising: superimposing two or more RF signals and transmitting the RF signals to an end effector; returning two or more RF signals on a common path via electrical contacts on at least one of an anvil or a channel frame of the end effector; and filtering the two or more RF signals prior to joining the RF signals on the common path.
12. Another embodiment provides the method of embodiment 11, further comprising: calculating an impedance associated with tissue compressed by the end effector based on at least one of the two or more RF signals.
13. Another embodiment provides the method of embodiment 11 or 12, wherein the two or more RF signals are superimposed via a multiplexer.
14. Another embodiment provides the method of any one of embodiments 11-13, wherein the two or more RF signals are generated by a frequency generator external to the end effector.
15. Another embodiment provides the method of any one of embodiments 12-14 wherein vertical tissue compression is calculated based on one of the RF signals and lateral tissue compression is calculated based on another of the RF signals.
16. Another embodiment provides the method of any one of embodiments 12-15 wherein a proximal tissue compression is calculated based on one of the RF signals and a distal tissue compression is calculated based on the other of the RF signals.
17. Another embodiment provides the method of any one of embodiments 11-16 wherein the two or more RF signals are filtered using two or more filters to distinguish individual tissue impedances represented by the two or more RF signals prior to joining the common return path.
18. Another embodiment provides the method of any one of embodiments 14-17, wherein the frequency generator is located on a circuit board of a shaft or handle of an endocutter.
In one aspect, the present disclosure provides an instrument 10 configured with various sensing systems (as described in connection with fig. 1-29). Accordingly, for the sake of brevity and clarity, details of operation and construction will not be repeated here. In one aspect, the sensing system includes a visco-elastic/rate of change sensing system to monitor blade acceleration, rate of change of impedance, and rate of change of tissue contact. In one example, the rate of change of blade acceleration may be used as a measure of tissue type. As another example, the rate of change of impedance may be measured using a pulse sensor and may be used as a measure of compressibility. Finally, a sensor may be utilized to measure the rate of change of tissue contact based on the knife firing rate to measure tissue flow.
The rate of change of the sensed parameter, or in other words the time required for the tissue parameter to reach the asymptotic steady state value, is itself a separate measure and may be more valuable than the sensed parameter from which the rate of change is derived. To enhance the measurement of tissue parameters (such as waiting a predetermined amount of time before making the measurement), the present disclosure provides novel techniques that employ a derivative of a metric (such as a rate of change of a tissue parameter).
The derivative technique or rate of change measurement becomes most useful in view of the fact that there is no single measurement available alone to significantly improve staple formation. Which is a combination of multiple metrics that makes a metric valid. In terms of tissue gap, it is beneficial to know the amount of jaw coverage by tissue to correlate the gap measure. The measure of the rate of change of the impedance can be combined with a measure of strain in the anvil to correlate the force to compression applied to tissue grasped between jaw members of the end effector, such as the anvil and the staple cartridge. The rate of change measure may be used by an endoscopic surgical device to determine tissue type rather than just tissue compression. Although stomach and lung tissue sometimes have similar thickness and even similar compression characteristics when calcification of lung tissue occurs, the instrument may be able to distinguish between these tissue types by employing a combination of measures such as gap, compression, applied force, tissue contact area, and rate of change of compression or rate of change of gap. If either of these measurements is used alone, the endoscopic surgical device may have difficulty distinguishing one tissue type from another. The rate of change of compression may also help to allow the device to determine if the tissue is "normal" or if there are some abnormalities. Measuring not only the amount of time that has elapsed but also the change in the sensor signal and determining the derivative of the signal will provide another measure to allow the endoscopic surgical device to measure the signal. The rate of change information may also be used to determine when a steady state has been reached, thereby signaling the next step in the process to proceed. For example, after clamping tissue between jaw members of an end effector (such as an anvil and a staple cartridge), an indicator or trigger can be activated to fire the device when the tissue compression reaches a steady state (e.g., about 15 seconds).
Methods, devices, and systems for time-dependent evaluation of sensor data are also provided herein to determine stability, creep, and viscoelastic properties of tissue during operation of a surgical instrument. The surgical instrument 10 (such as the stapler shown in fig. 1) may include a variety of sensors for measuring operating parameters such as jaw gap size or distance, firing current, tissue compression, amount of jaw coverage by tissue, anvil strain and trigger force, among others. These sensory measurements are important for the automatic control of the surgical instrument and to provide feedback to the clinician.
The examples shown in connection with fig. 30-49 may be used to measure various derivative parameters such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The motor current may be monitored using a current sensor 2312 in series with the battery 2308 as described in connection with fig. 24, a current sensor 2412 in series with the battery 2408 as shown in fig. 25, or a current sensor 3026 as shown in fig. 29.
Turning now to FIG. 50, a reusable or non-reusable motor driven surgical cutting and fastening instrument 8010 is illustrated. The motor-driven surgical cutting and fastening instrument 8010 is constructed and equipped similarly to the motor-driven surgical cutting and fastening instrument 10 described in connection with fig. 1-29. In the example shown in fig. 50, the instrument 8010 includes a housing 8012 that includes a handle assembly 8014 that is configured to be grasped, manipulated, and actuated by a clinician. The housing 8012 is configured for operable attachment to an interchangeable shaft assembly 8200 to which a surgical end effector 8300 is operably coupled, the surgical end effector being configured to perform one or more surgical tasks or surgical operations. Since the motor-driven surgical cutting and fastening instrument 8010 is constructed and equipped similarly to the motor-driven surgical cutting and fastening instrument 10 (fig. 1-4) described in connection with fig. 1-29, a detailed description of the operation and construction will not be repeated here for the sake of brevity and clarity.
The housing 8012 illustrated in fig. 50 is shown in conjunction with an interchangeable shaft assembly 8200 that includes an end effector 8300 that includes a surgical cutting and fastening device configured to operably support a surgical staple cartridge 8304 therein. Housing 8012 can be configured for use with interchangeable shaft assemblies that include end effectors configured to support staple cartridges of different sizes and types, and have different shaft lengths, sizes, types, and the like. Moreover, housing 8012 may also be usefully employed with a variety of other interchangeable shaft assemblies, including those that are configured to apply other motions and forms of energy, such as, for example, Radio Frequency (RF) energy, ultrasonic energy, and/or motion, to end effector arrangements suitable for use in connection with various surgical applications and procedures. Further, the end effector, shaft assembly, handle, surgical instrument, and/or surgical instrument system may utilize any suitable fastener or fasteners to fasten tissue. For example, a fastener cartridge including a plurality of fasteners removably stored therein can be removably inserted into and/or attached to an end effector of a shaft assembly.
Fig. 50 illustrates a surgical instrument 8010 having an interchangeable shaft assembly 8200 operably coupled thereto. In the illustrated construction, the handle housing forms a pistol grip portion 8019 that can be grasped and manipulated by a clinician. The handle assembly 8014 operably supports a plurality of drive systems therein that are configured to generate and apply various control actions to corresponding portions of an interchangeable shaft assembly operably attached thereto. A trigger 8032 is operatively associated with the pistol grip for controlling each of these control actions.
With continued reference to fig. 50, the interchangeable shaft assembly 8200 includes a surgical end effector 8300 including an elongate channel 8302 configured to operably support a staple cartridge 8304 therein. The end effector 8300 can also include an anvil 8306 that is pivotally supported relative to the elongate channel 8302.
The inventors have found that the derived parameters can be used to control a surgical instrument, such as the instrument shown in fig. 50, even more efficiently than the sensed parameters on which the derived parameters are based. Non-limiting examples of derived parameters include the rate of change of the sensed parameter (e.g., jaw gap distance) and the time (e.g., 15 seconds) elapsed before the tissue parameter reaches an asymptotic steady-state value. Derived parameters, such as rates of change, are particularly useful because they significantly improve measurement accuracy and also provide information that would otherwise not be apparent directly from the sensed parameters. For example, the rate of change of impedance (i.e., tissue compression) may be combined with the strain in the anvil to correlate compression to force, which may allow the microcontroller to determine the tissue type and not just the amount of tissue compression. This example is merely illustrative, and any derived parameter may be combined with one or more sensed parameters to provide more accurate information about tissue type (e.g., stomach versus lung), tissue health (e.g., calcified versus normal), and surgical instrument operating status (e.g., clamping complete). Different tissues have unique viscoelastic properties and unique rates of change, making these and other parameters discussed herein useful markers for monitoring and automatically adjusting a surgical procedure.
Fig. 52A-52E illustrate exemplary sensed parameters and parameters derived therefrom. Fig. 52A is an illustrative graph showing gap distance over time, where gap is the spacing between jaws occupied by clamped tissue. The vertical (y) axis is distance and the horizontal (x) axis is time. Specifically, referring to fig. 50 and 51, the gap distance 8040 is the distance between the anvil 8306 and the elongate channel 8302 of the end effector. In the open jaw position, the gap 8040 between the anvil 8306 and the elongate member is at its maximum distance. The width of the gap 8040 decreases, such as during tissue clamping, as the anvil 8306 closes. The rate of change of the T-gap distance may vary because the tissue has a non-uniform elasticity. For example, certain tissue types may initially be displayed with rapid compression, resulting in a faster rate of change. However, as the tissue continues to be compressed, the viscoelastic properties of the tissue may cause the rate of change to decrease until the tissue cannot be compressed further, at which time the gap distance will remain substantially constant. As tissue is compressed at the anvil 8306 and staple cartridge 8304 of the end effector 8040, the gap decreases over time. One or more sensors described in connection with fig. 30-49 and 55 (e.g., such as a magnetic field sensor, a strain gauge, a pressure sensor, a force sensor, an inductive sensor (such as an eddy current sensor, for example), a resistive sensor, a capacitive sensor, an optical sensor, and/or any other suitable sensor) may be modified and configured to measure a gap distance "d" between the anvil 8306 and the staple cartridge 8304 over time "t," as represented graphically in fig. 52A. The rate of change of the gap distance "d" with time "t" is the slope of the curve shown in fig. 52A, where the slope is Δ d/Δ t.
FIG. 52B is an illustrative graph showing firing current of end effector jaws. The vertical (y) axis is current and the horizontal (x) axis is time. As discussed herein, the surgical instrument and/or its microcontroller as shown in fig. 21-29 may include a current sensor that detects the current utilized during various operations, such as clamping, cutting, and/or stapling tissue. For example, as tissue impedance increases, the electric motor of the instrument may require more current to clamp, cut, and/or staple tissue. Similarly, if the impedance is low, the electric motor may require less current to clamp, cut, and/or staple tissue. Thus, the firing current may be used as an approximation of tissue impedance. The sensed current may be used alone or, more preferably, in combination with other metrics to provide feedback about the target tissue. Still referring to fig. 52B, during some operations (such as stapling), the firing current is initially high at time zero, but decreases over time. During operation of other devices, the current may increase over time if the motor consumes more current to overcome the increased mechanical load. In addition, the rate of change of firing current may be used as an indicator of tissue transition from one state to another. Thus, the firing current, and in particular the rate of change of the firing current, may be used to monitor device operation. As the knife cuts through tissue, the firing current may decrease over time. The rate of change of the firing current may vary if the tissue being cut provides a higher or lower impedance due to the tissue characteristics or the sharpness of the knife 8305 (fig. 51). When the cutting state changes, the work done by the motor changes and thus the firing current over time will change. The current sensor may be used to measure firing current over time during the positive firing of the knife 8305, as represented graphically in fig. 52B. For example, the motor current may be monitored using the current sensor 2312 in series with the battery 2308 as described in connection with FIG. 24, the current sensor 2412 in series with the battery 2408 as shown in FIG. 25, or the current sensor 3026 as shown in FIG. 29. The current sensor 2312,2314,3026 may be configured and configured to measure a motor firing current "i" over time "t", as represented diagrammatically in fig. 52B. The rate of change of the firing current "i" with time "t" is the slope of the curve shown in fig. 52B, where the slope is Δ i/Δ t.
Fig. 52 is an explanatory diagram of impedance with time. The vertical (y) axis is impedance and the horizontal (x) axis is time. At time zero, the impedance is low, but increases over time as tissue pressure increases under manipulation (e.g., clamping and stapling). The rate of change changes over time as the tissue between the anvil 8306 and staple cartridge 8304 of the end effector 8040 is severed by a knife or sealed using RF energy between electrodes located between the anvil 8306 and staple cartridge 8304 of the end effector 8040. For example, as tissue is cut, the electrical impedance increases and reaches infinity when the tissue is completely severed by the knife. Additionally, if the end effector 8040 includes electrodes coupled to a source of RF energy, the electrical impedance of the tissue increases as energy is delivered through the tissue between the anvil 8306 and staple cartridge 8304 of the end effector 8040. The electrical impedance increases as the energy passing through the tissue dries out the tissue by evaporating water from the tissue. Finally, when the appropriate amount of energy is delivered to the tissue, the impedance increases to a very high value or infinity when the tissue is severed. In addition, as shown in fig. 52C, different tissues may have unique compression characteristics, such as compression rate, which may differentiate the tissues. Tissue impedance may be measured by driving a subtherapeutic RF current through tissue grasped between the first jaw member 9014 and the second jaw member 9016. One or more electrodes may be positioned on one or both of the anvil 8306 and staple cartridge 8304. Tissue compression/impedance over time of the tissue between the anvil 8306 and the staple cartridge 8304 may be measured, as graphically represented in fig. 52C. The sensors described in connection with fig. 30-49 and 55 (e.g., such as magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors (such as eddy current sensors, for example), resistive sensors, capacitive sensors, optical sensors, and/or any other suitable sensors) may be capable of and configured to measure tissue compression/impedance. These sensors may be capable of and configured to measure tissue impedance "Z" over time "t", as represented diagrammatically in fig. 52C. The rate of change of tissue impedance "Z" over time "t" is the slope of the curve shown in fig. 78C, where the slope is Δ Z/Δ t.
Fig. 52D is an exemplary graph of anvil 8306 (fig. 50, 51) strain over time. The vertical (y) axis is strain and the horizontal (x) axis is time. During stapling, for example, the anvil 8306 strain is initially high, but decreases as the tissue reaches steady state and less pressure is applied to the anvil 8306. The rate of change of the anvil 8306 strain may be measured by a pressure sensor or strain gauge positioned on either or both of the anvil 8306 and the staple cartridge 8304 (fig. 50, 51) to measure the pressure or strain applied to tissue grasped between the anvil 8306 and the staple cartridge 8304. The anvil 8306 strain may be measured over time as graphically represented in fig. 52D. The rate of change of strain "S" over time "t" is the slope of the curve shown in fig. 52D, where the slope is Δ S/Δ t.
Fig. 52E is an exemplary graph of trigger force over time. The vertical (y) axis is trigger force and the horizontal (x) axis is time. In some examples, the trigger force is progressive, providing tactile feedback to the clinician. Thus, at time zero, trigger 8020 (fig. 50) can be at its minimum and the trigger pressure can be increased before the operation (e.g., clamping, cutting, or stapling) is completed. The rate of change of trigger force can be measured by a pressure sensor or strain gauge positioned on the trigger 8302 of the handle 8019 of the instrument 8010 (fig. 50) to measure the force required to drive the knife 8305 (fig. 51) through tissue grasped between the anvil 8306 and staple cartridge 8304. Trigger 8032 force can be measured over time, as graphically represented in fig. 52E. The rate of change of the strain trigger force "F" over time "t" is the slope of the curve shown in fig. 52E, where the slope is Δ F/Δ t.
For example, stomach and lung tissue may be distinguished even though these tissues may have similar thicknesses and, in the case of calcification of lung tissue, may have similar compression properties. Gastric and pulmonary tissue can be distinguished by analyzing the jaw gap distance, tissue compression, applied force, tissue contact area, rate of change of compression, and rate of change of jaw gap. For example, fig. 53 shows a graph of tissue pressure "P" versus tissue displacement for various tissues. The vertical (y) axis is tissue pressure and the horizontal (x) axis is tissue displacement. When the tissue pressure reaches a predetermined threshold, such as 50-100 pounds per square inch (psi), the amount of tissue displacement before the threshold is reached, as well as the rate of tissue displacement, can be used to differentiate between tissues. For example, vascular tissue reaches a predetermined pressure threshold with less tissue displacement and a faster rate of change than colon, lung, or stomach tissue. In addition, the rate of change of vascular tissue (tissue pressure versus displacement) is asymptotic at a threshold of 50-100psi, whereas the rate of change of colon, lung and stomach is not asymptotic at a threshold of 50-100 psi. As will be appreciated, any pressure threshold may be used, for example between 1 and 1000psi, more preferably between 10 and 500psi, more preferably between 50 and 100 psi. In addition, multiple thresholds or progressive thresholds may be used to provide further discrimination of tissue types having similar viscoelastic properties.
The rate of change of compression may also allow the microcontroller to determine if the tissue is "normal" or if there are some abnormalities (such as calcification). For example, referring to fig. 54, the compression of calcified lung tissue follows a different curve than the compression of normal lung tissue. Tissue displacement and the rate of change of tissue displacement can therefore be used to diagnose and/or differentiate calcified lung tissue from normal lung tissue.
Additionally, certain sensed metrics may benefit from additional sensor inputs. For example, in terms of jaw gap, knowing the extent to which the jaws are covered by tissue can make the gap measurement more useful and accurate. If a small portion of the jaws are covered by tissue, the tissue compression may appear to be less than if the entire jaws are covered by tissue. Thus, the amount of jaw coverage can be taken into account by the microcontroller when analyzing tissue compression and other sensed parameters.
In some cases, elapsed time may also be an important parameter. Measuring elapsed time and combining the sensed parameter and the derived parameter (e.g., rate of change) provides additional useful information. For example, if the rate of change of the jaw gap remains constant after a set period of time (e.g., 5 seconds), the parameter may have reached its asymptotic value.
The rate of change information may also be used to determine when a steady state has been reached, thereby signaling the next step in the process to proceed. For example, during clamping, when tissue compression reaches steady state (e.g., no significant rate of change occurs after a set period of time), the microcontroller may send a signal to the display, thereby prompting the clinician to initiate the next step in the procedure, such as staple firing. Alternatively, the microcontroller may be programmed to automatically initiate the next stage in operation (e.g., staple firing) once a steady state is reached.
Similarly, the rate of change of resistance may be combined with strain in the anvil to correlate force with compression. The rate of change will allow the device to determine the tissue type rather than just measure the compression value. For example, stomach and lung tissue sometimes have similar thicknesses and even similar compression characteristics when calcification of the lung occurs.
The combination of the one or more sensed parameters with the derived parameters provides a more reliable and accurate assessment of tissue type and tissue health status and allows for better tissue monitoring, control and clinician feedback.
Referring now to fig. 55, the end effector 9012 is an aspect of the end effector 8300 (fig. 50) that may be operable with the surgical instrument 8010 (fig. 50) to measure various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time. Thus, the end effector 9012 illustrated in fig. 55 may include one or more sensors configured to measure one or more parameters or characteristics associated with the end effector 9012 and/or the tissue segment captured by the end effector 9012. In the example shown in fig. 55, the end effector 9012 includes a first sensor 9020 and a second sensor 9026. In various examples, the first sensor 9020 and/or the second sensor 9026 may include, for example, a magnetic sensor (such as, for example, a magnetic field sensor), a strain gauge, a pressure sensor, a force sensor, an inductive sensor (such as, for example, an eddy current sensor), a resistive sensor, a capacitive sensor, an optical sensor, and/or any other suitable sensor for measuring one or more parameters of the end effector 9012.
In certain instances, the first sensor 9020 and/or the second sensor 9026 can comprise, for example, a magnetic field sensor embedded in the first jaw member 9014 and configured to detect a magnetic field generated by a magnet 9024 embedded in the second jaw member 9016 and/or the staple cartridge 9018. The strength of the detected magnetic field may correspond to, for example, the thickness and/or fullness of a small piece of tissue positioned between jaw members 9014,9016. In certain examples, the first sensor 9020 and/or the second sensor 9026 may include a strain gauge, such as, for example, a micro-strain gauge, configured to measure a magnitude of strain in the anvil 9014 during the clamped condition. The strain gauge provides an electrical signal whose magnitude varies with the magnitude of the strain.
In some aspects, one or more sensors of the end effector 9012 (such as, for example, the first sensor 9020 and/or the second sensor 9026) may include a pressure sensor configured to detect a pressure resulting from the presence of compressed tissue between the jaw members 9014,9016. In some examples, one or more sensors of the end effector 9012 (e.g., such as the first sensor 9020 and/or the second sensor 9026) are configured to detect an impedance of a tissue segment located between the jaw members 9014,9016. The detected impedance may be indicative of the thickness and/or integrity of tissue located between the jaw members 9014, 9016.
In one aspect, one or more of the sensors of the end effector 9012 (such as the first sensor 9012, for example) is configured to measure a gap 9022 between the anvil 9014 and the second jaw member 9016. In some instances, the gap 9022 may represent a thickness and/or compressibility of the tissue segment clamped between the jaw members 9014, 9016. In at least one example, the gap 9022 can be equal or substantially equal to a thickness of a tissue segment clamped between the jaw members 9014, 9016. In one example, one or more of the sensors of the end effector 9012 (e.g., such as the first sensor 9020) is configured to measure one or more forces exerted on the anvil 9014 by the second jaw member 9016 and/or tissue clamped between the anvil 9014 and the second jaw member 9016. The force applied to the anvil 9014 may be indicative of tissue compression experienced by the tissue segment captured between the jaw members 9014, 9016. In one embodiment, the gap 9022 between the anvil 9014 and the second jaw member 9016 may be measured by: a magnetic field sensor is positioned on the anvil 9014 and a magnet is positioned on the second jaw member 9016 such that the gap 9022 is proportional to the signal detected by the magnetic field sensor and the signal is proportional to the distance between the magnet and the magnetic field sensor. It should be appreciated that the positions of the magnetic field sensor and the magnet may be interchanged such that the magnetic field sensor is positioned on the second jaw member 9016 and the magnet is placed on the anvil 9014.
One or more of these sensors may be measured in real time during the gripping operation, such as, for example, the first sensor 9020 and/or the second sensor 9026. The real-time measurements allow time-based information to be analyzed by, for example, a processor and used to select one or more algorithms and/or look-up tables for evaluating manual inputs by an operator of the surgical instrument 9010 in real-time. Further, real-time feedback may be provided to the operator to assist the operator in correcting the manual inputs to produce a desired output.
The present disclosure will now be described in conjunction with various embodiments and combinations of such embodiments, which are set forth below.
1. One embodiment provides a powered surgical cutting and stapling instrument comprising: at least one sensor for measuring, at least one processor, at least one parameter associated with the instrument; and a memory operatively associated with the processor, the memory comprising machine executable instructions that, when executed by the processor, cause the processor to: monitoring the at least one sensor for a predetermined period of time; and determining a rate of change of the measured parameter.
2. Another embodiment provides the powered surgical cutting and stapling instrument of embodiment 1, comprising an end effector comprising a first jaw member and a second jaw member, wherein at least one of the first jaw member and the second jaw member is movable relative to the other jaw member, and wherein the at least one sensor is positioned on at least one of the first jaw member and the second jaw member.
3. Another embodiment provides the powered surgical cutting and stapling instrument of embodiment 2, further comprising: a magnet positioned on the first jaw member; a magnetic field sensor, wherein the magnetic field sensor is coupled to the processor and the processor is configured to determine a gap distance between the first jaw member and the second jaw member based on a signal received from the magnetic field sensor, wherein the signal from the magnetic field sensor is proportional to the gap distance between the magnet and the magnetic field sensor, wherein the processor is configured to monitor the gap distance over the predetermined period of time to determine a rate of change of the gap over the predetermined period of time.
4. Another embodiment provides the powered surgical cutting and stapling instrument of embodiment 2 or 3, further comprising: a knife channel defined in at least one of the first or second jaw members, wherein the channel is configured to translate a knife therealong; a knife configured to translate along the knife channel; a motor operatively coupled to the knife to advance and retract the knife along the knife channel; and a current sensor configured to measure a current draw of the motor as the motor advances the knife to cut tissue grasped between the first and second jaw members; wherein the processor is configured to receive a signal from the current sensor over the predetermined period of time, wherein the signal is representative of the current draw of the motor when advancing the knife through the tissue; and wherein the processor is configured to determine a rate of change of the current draw of the motor as the motor advances the knife through the tissue within the predetermined period of time.
5. Another embodiment provides the powered surgical instrument of any one of embodiments 2-4, further comprising a force sensor positioned in at least one of the first jaw member or the second jaw member to measure compression of tissue grasped between the first jaw member and the second jaw member, wherein the processor is configured to receive a signal from the force sensor over the predetermined period of time, wherein the signal is representative of the tissue compression, and wherein the processor is configured to determine a rate of change of tissue compression over the predetermined period of time.
6. Another embodiment provides the powered surgical instrument of any of embodiments 2-5, further comprising at least one electrode coupled to a subtherapeutic Radio Frequency (RF) energy source configured to drive a low energy level RF signal through tissue grasped between the first and second jaw members to measure electrical impedance of the tissue; wherein the processor is configured to receive a signal from the at least one electrode over the predetermined period of time, wherein the signal is representative of the tissue impedance, and wherein the processor is configured to determine a rate of change of the tissue impedance over the predetermined period of time.
7. Another embodiment provides the powered surgical instrument of any one of embodiments 2-6, further comprising a strain gauge positioned in a movable jaw member of the first or second jaw members to measure a strain of the jaw members when tissue is grasped between the first and second jaw members, wherein the processor is configured to receive a signal from the strain gauge over the predetermined period of time, wherein the signal is representative of the strain of the movable jaw member, and wherein the processor is configured to determine a rate of change of the strain over the predetermined period of time.
8. Another embodiment provides the powered surgical cutting and stapling instrument of any one of embodiments 1-7, comprising: a handle; a trigger movable relative to the handle; and a pressure sensor or strain gauge positioned on the moveable trigger, wherein the processor is configured to receive a signal from the strain gauge over the predetermined period of time, wherein the signal is representative of a force applied to the moveable trigger, and wherein the processor is configured to determine a rate of change of the force over the predetermined period of time.
9. Another embodiment provides a powered surgical cutting and stapling instrument including: an end effector comprising a first jaw member and a second jaw member, wherein at least one of the first jaw member and the second jaw member is movable relative to the other jaw member, and wherein the at least one sensor is positioned on at least one of the first jaw member and the second jaw member; a pressure sensor or strain gauge positioned in at least one of the first jaw member or the second jaw member; at least one processor; a memory operatively associated with the processor, the memory comprising machine executable instructions that, when executed by the processor, cause the processor to: monitoring pressure applied to tissue grasped between the first and second jaw members; and determining a type of tissue grasped between the first jaw member and the second jaw member based on the tissue pressure measurements.
10. Another embodiment provides the powered surgical instrument of embodiment 9, wherein the processor is configured to determine tissue displacement by measuring tissue pressure along a first axis and along a second axis, wherein the first axis and the second axis are transverse relative to each other.
11. Another embodiment provides the powered surgical instrument of embodiment 10, wherein when tissue pressure reaches a predetermined threshold, the amount of tissue displacement and the rate of tissue displacement before the threshold is reached are used to differentiate between tissue types.
12. Another embodiment provides the powered surgical instrument of embodiment 10 or 11, wherein the processor is configured to determine tissue displacement based on a plurality of thresholds or progressive thresholds to provide higher resolution of tissue types having similar viscoelastic properties.
13. Another embodiment provides a powered surgical cutting and stapling instrument including: an end effector comprising a first jaw member and a second jaw member, wherein at least one of the first jaw member and the second jaw member is movable relative to the other jaw member, and wherein the at least one sensor is positioned on at least one of the first jaw member and the second jaw member; a pressure sensor or strain gauge positioned in at least one of the first jaw member or the second jaw member; a gap sensor for measuring a gap distance between the first jaw member and the second jaw member; at least one processor; a memory operatively associated with the processor, the memory comprising machine executable instructions that, when executed by the processor, cause the processor to: monitoring pressure applied to tissue grasped between the first and second jaw members; monitoring the gap distance between the first jaw member and the second jaw member; and determining a type of tissue grasped between the first jaw member and the second jaw member based on the tissue pressure and the gap distance measurement.
14. Another embodiment provides the powered surgical cutting and stapling instrument of embodiment 13, wherein the processor determines an amount of tissue grasped between the first jaw member and the second jaw member using the pressure and gap distance measurements.
15. Another embodiment provides the powered surgical cutting and stapling instrument of embodiment 14, wherein the processor is configured to compensate for tissue compression measurements when a small portion of the first and second jaw members are covered in tissue.
16. Another embodiment provides the powered surgical cutting and stapling instrument of embodiment 14 or 15, wherein the processor is configured to determine a derivative parameter by determining an elapsed time in conjunction with the pressure and gap distance measurements.
17. Another embodiment provides the powered surgical cutting and stapling instrument of embodiment 16, wherein the processor is configured to determine that the measured parameter has reached a gradual value when the rate of change remains constant after a set period of time.
18. Another embodiment provides the powered surgical cutting and stapling instrument of embodiment 16 or 17, wherein the processor employs rate of change information to determine when a steady state has been reached to signal a next step in the process.
19. Another embodiment provides the powered surgical cutting and stapling instrument of embodiment 18, wherein the processor is configured to send a signal to a display to alert a user of the instrument to begin a next step in the procedure, or the processor is configured to automatically begin the next step of the procedure once a steady state is reached.
20. Another embodiment provides the powered surgical cutting and stapling instrument of any one of embodiments 16-19, wherein the processor is configured to combine a rate of change of impedance with strain in at least one of the first jaw member and the second jaw member to correlate force and compression.
According to various embodiments, the surgical instruments described herein may include one or more processors (e.g., microprocessors, microcontrollers) coupled to various sensors. In addition, a memory (having operating logic) and a communication interface are coupled to one or more processors.
As previously described, the sensor may be configured to detect and collect data associated with the surgical device. The processor processes sensor data received from the sensors.
The processor may be configured to execute the operating logic. The processor may be any of a number of single-core or multi-core processors known in the art. The storage device may include volatile and non-volatile storage media configured to store permanent and temporary (working) copies of the operating logic.
In various aspects, the operating logic may be configured to perform initial processing and transmit data to a computer hosting the application to determine and generate instructions. For these embodiments, the operational logic may be further configured to receive information from the hosted computer and provide feedback thereto. In alternative embodiments, the operational logic may be configured to play a more important role in receiving information and determining feedback. In either case, whether determined independently or in response to instructions from a host computer, the operating logic may be further configured to control and provide feedback to the user.
In various aspects, the operational logic may be implemented by instructions supported by an Instruction Set Architecture (ISA) of the processor, or in a higher-level language, and compiled into a supported ISA. The operational logic may include one or more logic units or modules. The operation logics may be implemented in an object-oriented manner. The operating logic may be configured to be executable in a multitasking manner and/or a multithreading manner. In other examples, the operational logic may be implemented in hardware, such as a gate array.
In various aspects, the communication interface may be configured to facilitate communication between the peripheral device and the computing system. The communication may include transmitting the collected biometric data associated with the position, the gesture, and/or the motion data of the user's body part to a host computer, and transmitting data associated with the haptic feedback from the host computer to the peripheral device. In various embodiments, the communication interface may be a wired or wireless communication interface. Examples of wired communication interfaces may include, but are not limited to, a Universal Serial Bus (USB) interface. Examples of wireless communication interfaces may include, but are not limited to, a bluetooth interface.
For various aspects, a processor may be packaged with operating logic. In various embodiments, a processor may be packaged with operating logic to form a SiP. In various embodiments, the processors may be integrated with the operational logic on the same die. In various embodiments, a processor may be packaged with operating logic to form a system on a chip (SoC).
Various aspects may be described herein in the general context of computer-executable instructions, such as software, program modules, and/or engines being executed by a processor. Generally, software, program modules, and/or engines include any software elements arranged to perform particular operations or implement particular abstract data types. Software, program modules, and/or engines may include routines, programs, objects, components, data structures, etc. that perform particular tasks or implement particular abstract data types. Specific implementations of software, program modules, and/or engine components and techniques may be stored on and/or transmitted across some form of computer readable media. In this regard, computer readable media can be any available media that can be used to store information and that can be accessed by a computing device. Some examples may also be practiced in distributed computing environments where operations are performed by one or more remote processing devices that are linked through a communications network. In a distributed computing environment, software, program modules, and/or engines may be located in both local and remote computer storage media including memory storage devices. A memory, such as a Random Access Memory (RAM) or other dynamic storage device, may be employed to store information and instructions to be executed by the processor. The memory may also be used for storing temporary variables or other intermediate information during execution of instructions to be executed by the processor.
While some aspects may be illustrated and described as comprising functional components, software, engines, and/or modules performing various operations, it should be appreciated that such components or modules may be implemented by one or more hardware components, software components, and/or combinations thereof. The functional components, software, engines, and/or modules may be implemented by, for example, logic (e.g., instructions, data, and/or code) to be executed by a logic device (e.g., a processor). Such logic may be stored internally or externally to a logic device on one or more types of computer-readable storage media. In other examples, functional components (such as software, engines, and/or modules) may be implemented by hardware elements that may include processors, microprocessors, circuits, circuit elements (e.g., transistors, resistors, capacitors, inductors, and so forth), integrated circuits, ASICs, PLDs, DSPs, FPGAs, logic gates, registers, semiconductor device, chips, microchips, chip sets, and so forth.
Examples of software, engines, and/or modules may include software components, programs, applications, computer programs, application programs, system programs, machine programs, operating system software, middleware, firmware, software modules, routines, subroutines, functions, methods, procedures, software interfaces, Application Program Interfaces (API), instruction sets, computing code, computer code, code segments, computer code segments, words, values, symbols, or any combination thereof. Determining whether an embodiment is implemented using hardware elements and/or software elements may vary in accordance with any number of factors, such as desired computational rate, power levels, heat tolerances, processing cycle budget, input data rates, output data rates, memory resources, data bus speeds and other design or performance constraints.
One or more of the modules described herein may include one or more embedded applications implemented as firmware, software, hardware, or any combination thereof. One or more of the modules described herein may include various executable modules such as software, programs, data, drivers, application APIs, and the like. The firmware may be stored in the controller and/or a memory of the controller, such as a bit-mask read-only memory (ROM) or flash memory, which may include a non-volatile memory (NVM). In various implementations, storing firmware in ROM may protect flash memory. NVM may include other types of memory including, for example, programmable rom (prom), erasable programmable rom (eprom), EEPROM, or battery backed RAM (such as dynamic RAM (dram), double data rate dram (ddram), and/or synchronous dram (sdram)).
In some cases, various aspects may be implemented as an article of manufacture. The article of manufacture may comprise a computer-readable storage medium arranged to store logic, instructions, and/or data for performing various operations of one or more examples. In various examples, the article of manufacture may comprise, for example, a magnetic disk, optical disk, flash memory, or firmware, each containing computer program instructions adapted for execution by a general-purpose processor or a special-purpose processor. However, the embodiments are not limited thereto.
The functions of the various functional elements, logic blocks, modules, and circuit elements described in connection with the embodiments disclosed herein may be implemented in the general context of computer-executable instructions, such as software, control modules, logic, and/or logic modules, being executed by a processing unit. Generally, software, control modules, logic, and/or logic modules include any software elements arranged to perform particular operations. Software, control modules, logic, and/or logic modules may include routines, programs, objects, components, data structures, etc. that perform particular tasks or implement particular abstract data types. Implementations of software, control modules, logic, and/or logic modules and techniques may be stored on and/or transmitted across some form of computer readable media. In this regard, computer readable media can be any available media that can be used to store information and that can be accessed by a computing device. Some examples may also be practiced in distributed computing environments where operations are performed by one or more remote processing devices that are linked through a communications network. In a distributed computing environment, software, control modules, logic, and/or logic modules may be located in both local and remote computer storage media including memory storage devices.
Further, it is to be understood that the aspects described herein set forth example implementations, and that the functional elements, logic blocks, modules, and circuit elements may be implemented in various other ways consistent with the described embodiments. Further, operations performed by such functional elements, logic blocks, modules, and circuit elements may be combined and/or separated for a given implementation and may be performed by a greater or lesser number of components or modules. As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several aspects without departing from the scope of the present disclosure. Any described method may be performed in the order of events described, or in any other logically possible order.
It is worthy to note that any reference to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. The appearances of the phrase "in one embodiment" or "in one aspect" in various places in the specification are not necessarily all referring to the same embodiment.
Unless specifically stated otherwise, it may be appreciated that terms such as "processing," "computing," "calculating," "determining," or the like, refer to the action and/or processes of a computer or computing system, or similar electronic computing device, such as a general purpose processor, a DSP, an ASIC, an FPGA or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof, that is designed to perform the functions described herein, manipulate and/or transform data represented as physical quantities (e.g., electronic) within registers and/or memories into other data similarly represented as physical quantities within the memories, registers or other such information storage, transmission or display devices.
It is worthy to note that some aspects may be described using the expression "coupled" and "connected" along with their derivatives. These terms are not intended as synonyms for each other. For example, some aspects may be described using the terms "connected" and/or "coupled" to indicate that two or more elements are in direct physical or electrical contact with each other. The term "coupled," however, may also mean that two or more elements are not in direct contact with each other, but yet still co-operate or interact with each other. In terms of software elements, for example, the term "coupled" may refer to an interface, message interface, API, exchange message, and the like.
It should be understood that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. Likewise, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
The present disclosure is applicable to conventional endoscopy and open surgical instruments as well as applications in robotic-assisted surgery.
Various aspects of the devices disclosed herein may be designed to be disposed of after a single use, or they may be designed for multiple uses. In either or both of the above cases, the embodiments may be reconditioned for reuse after at least one use. The repair may include any combination of the following steps: disassembly of the device, followed by cleaning or replacement of particular parts and subsequent reassembly. In particular, embodiments of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular components, embodiments of the device may be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. The use of such techniques and the resulting prosthetic devices are all within the scope of the present application.
By way of example only, aspects described herein may be processed prior to surgery. First, new or used instruments may be obtained and cleaned as needed. The instrument may then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container such as a plastic or TYVEK bag. The container and instrument may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, X-rays, or high-energy electrons. The radiation may kill bacteria on the instrument and in the container. The sterilized instrument may then be stored in a sterile container. Sealing the container may maintain the instrument in a sterile state until the container is opened in a medical facility. The device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, plasma peroxide, or steam.
Those skilled in the art will recognize that the components (e.g., operations), devices, objects, and their accompanying discussion described herein are for conceptual clarity purposes only and that various configuration modifications are possible. Thus, as used herein, the specific examples set forth and the accompanying discussion are intended to be representative of their more general categories. In general, the use of any particular example is intended to be representative of its class, and non-included portions of particular components (e.g., operations), devices, and objects should not be taken to be limiting.
With respect to substantially any plural and/or singular terms used herein, those having skill in the art can translate from the plural to the singular and/or from the singular to the plural as is appropriate to the context and/or application. Various singular/plural permutations are not expressly set forth herein for the sake of clarity.
The subject matter described herein sometimes sets forth different components contained within or connected with different other components. It is to be understood that such depicted architectures are merely examples, and that in fact many other architectures can be implemented which achieve the same functionality. In a conceptual sense, any arrangement of components to achieve the same functionality is effectively "associated" such that the desired functionality is achieved. Hence, any two components herein combined to achieve a particular functionality can be seen as "associated with" each other such that the desired functionality is achieved, irrespective of architectures or intermedial components. Likewise, any two components so associated can also be viewed as being "operably connected," or "operably coupled," to each other to achieve the desired functionality, and any two components capable of being so associated can also be viewed as being "operably couplable," to each other to achieve the desired functionality. Specific examples of operably couplable include, but are not limited to, physically mateable and/or physically interacting components, and/or wirelessly interactable, and/or wirelessly interacting components, and/or logically interacting components.
Some aspects may be described using the expression "coupled" and "connected" along with their derivatives. It should be understood that these terms are not intended as synonyms for each other. For example, some aspects may be described using the term "connected" to indicate that two or more elements are in direct physical or electrical contact with each other. In another example, some aspects may be described using the term "coupled" to indicate that two or more elements are in direct physical or electrical contact. The term "coupled," however, may also mean that two or more elements are not in direct contact with each other, but yet still co-operate or interact with each other.
In some instances, one or more components may be referred to herein as "configured to," "configurable to," "operable/operable," "adapted/adapted," "able," "adapted/adapted," or the like. Those skilled in the art will recognize that "configured to" may generally encompass components in an active state and/or components in an inactive state and/or components in a standby state unless the context indicates otherwise.
While particular aspects of the present subject matter described herein have been shown and described, it will be obvious to those skilled in the art that, based upon the teachings herein, changes and modifications may be made without departing from the subject matter described herein, and it is intended to cover in its broader aspects and, therefore, the appended claims all such changes and modifications as are within the true scope of the subject matter described herein. It will be understood by those within the art that, in general, terms used herein, and especially in the appended claims (e.g., bodies of the appended claims) are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "includes but is not limited to," etc.). It will be further understood by those within the art that when a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases "at least one" and "one or more" to introduce claims. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles "a" or "an" limits any particular claim containing such introduced claim recitation to claims containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "a" and/or "an" should typically be interpreted to mean "at least one" or "one or more"); this also applies to the use of definite articles used to introduce claim recitations.
In addition, even when a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of "two recitations," without other modifiers, typically means at least two recitations, or two or more recitations). Further, in those instances where a convention analogous to "at least one of A, B and C, etc." is used, in general such a construction is intended to have a meaning that one of ordinary skill in the art would understand the convention (e.g., "a system having at least one of A, B and C" would include, but not be limited to, systems having a alone, B alone, C, A and B together alone, a and C together, B and C together, and/or A, B and C together, etc.). In those instances where a convention analogous to "A, B or at least one of C, etc." is used, in general such a construction is intended to have a meaning that one of skill in the art would understand the convention (e.g., "a system having at least one of A, B or C" would include, but not be limited to, systems having a alone, B alone, C, A and B together alone, a and C together, B and C together, and/or A, B and C together, etc.). It will also be understood by those within the art that, in general, disjunctive words and/or phrases having two or more alternative terms, whether appearing in the detailed description, claims, or drawings, should be understood to encompass the possibility of including one of the terms, either of the terms, or both terms, unless the context indicates otherwise. For example, the phrase "a or B" will generally be understood to include the possibility of "a" or "B" or "a and B".
Those skilled in the art will appreciate from the appended claims that the operations recited therein may generally be performed in any order. In addition, while the various operational flows are listed in a certain order, it should be understood that the various operations may be performed in an order other than the order shown, or may be performed simultaneously. Examples of such alternative orderings may include overlapping, interleaved, interrupted, reordered, incremental, preliminary, complementary, simultaneous, reverse, or other altered orderings, unless context dictates otherwise. Furthermore, unless the context dictates otherwise, terms like "responsive," "related," or other past adjectives are generally not intended to exclude such variations.
In summary, a number of benefits resulting from employing the concepts described herein have been described. The foregoing disclosure has been presented for purposes of illustration and description. The description is not intended to be exhaustive or to limit the invention to the precise form disclosed. Modifications or variations are possible in light of the above teachings. The embodiment or embodiments were chosen and described in order to explain the principles of the invention and its practical application to enable one skilled in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. The claims as filed herewith are intended to define the full scope.

Claims (12)

1. A powered surgical cutting and stapling instrument comprising:
at least one sensor that measures at least one parameter associated with the powered surgical cutting and stapling instrument;
an end effector comprising a first jaw member and a second jaw member, wherein at least one of the first jaw member and the second jaw member is movable relative to the other jaw member, and wherein the at least one sensor is positioned on at least one of the first jaw member and the second jaw member;
a pressure sensor or strain gauge positioned in at least one of the first jaw member or the second jaw member;
at least one processor;
a memory operatively associated with the processor, the memory comprising machine executable instructions that, when executed by the processor, cause the processor to:
monitoring pressure applied to tissue grasped between the first and second jaw members; and is
Determining a type of tissue grasped between the first jaw member and the second jaw member based on the tissue pressure measurements, the measured parameters, and a comparison to stored values for known tissue types,
wherein the measured parameters are:
a resistance of tissue grasped between the first and second jaw members;
the amount of tissue displacement; or
A gap distance between the first jaw and the second jaw member.
2. The powered surgical cutting and stapling instrument of claim 1, wherein the at least one sensor is a pressure sensor that measures a force applied to tissue clamped by the end effector, wherein the processor is configured to determine tissue displacement by measuring tissue pressure along a first axis and along a second axis, wherein the first and second axes are transverse relative to each other, wherein a vertical force is applied along the first axis by the first and second jaw members of the end effector while tissue is clamped.
3. The powered surgical cutting and stapling instrument of claim 2, wherein when tissue pressure reaches a predetermined threshold, the machine executable instructions, when executed by the processor, further cause the processor to distinguish tissue types using an amount of tissue displacement and a rate of tissue displacement prior to reaching the threshold.
4. The powered surgical cutting and stapling instrument of claim 1, wherein the processor is configured to determine tissue displacement based on a plurality of thresholds or progressive thresholds to provide higher resolution of tissue types having similar viscoelastic properties.
5. The powered surgical cutting and stapling instrument of claim 1, wherein at least one sensor is a gap sensor for measuring a gap distance between the first jaw member and the second jaw member, wherein the machine-executable instructions, when executed by the processor, further cause the processor to:
monitoring the gap distance between the first jaw member and the second jaw member; and is
Determining a type of tissue grasped between the first jaw member and the second jaw member based on the tissue pressure and the gap distance measurement.
6. The powered surgical cutting and stapling instrument of claim 5, wherein the processor uses the pressure and gap distance measurements to determine an amount of tissue grasped between the first jaw member and the second jaw member.
7. The powered surgical cutting and stapling instrument of claim 6, wherein the processor is configured to compensate for tissue compression measurements when a small portion of the first and second jaw members are covered in tissue.
8. The powered surgical cutting and stapling instrument of claim 6, wherein the processor is configured to determine a derivative parameter by determining an elapsed time in conjunction with pressure and gap distance measurements.
9. The powered surgical cutting and stapling instrument of claim 8, wherein the processor is configured to determine that the measured parameter has reached a gradual value when a rate of change of the measured parameter remains constant after a set period of time.
10. The powered surgical cutting and stapling instrument of claim 9, wherein the processor employs a determination that the measured parameter has reached a steady state value by signaling a next step in the process.
11. The powered surgical cutting and stapling instrument of claim 10, wherein the processor is configured to send a signal to a display to alert a user of the instrument to begin a next step in the procedure, or the processor is configured to automatically begin the next step of the procedure once a steady state is reached.
12. The powered surgical cutting and stapling instrument of claim 8, wherein the processor is configured to combine a rate of change of impedance with strain in at least one of the first and second jaw members to correlate force and compression.
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US14/640,935 US10548504B2 (en) 2015-03-06 2015-03-06 Overlaid multi sensor radio frequency (RF) electrode system to measure tissue compression
US14/640,859 US10052044B2 (en) 2015-03-06 2015-03-06 Time dependent evaluation of sensor data to determine stability, creep, and viscoelastic elements of measures
PCT/US2016/020169 WO2016144601A1 (en) 2015-03-06 2016-03-01 Time dependent evaluation of sensor data to determine stability, creep, and viscoelastic elements of measures

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